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510(k) K091984

IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 by Siemens Medical Solutions Diagnostics — Product Code DHB

K091984 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions Diagnostics for the device "IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6". The FDA issued a decision of Substantially Equivalent on October 28, 2009. The device falls under product code DHB (System, Test, Radioallergosorbent (Rast) Immunological), a Class II device regulated under 21 CFR 866.5750. Siemens Medical Solutions Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2009
Date Received
July 2, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Radioallergosorbent (Rast) Immunological
Device Class
Class II
Regulation Number
866.5750
Review Panel
IM
Submission Type

Other clearances by Siemens Medical Solutions Diagnostics

  • K100910 — IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 (May 11, 2011)
  • K081895 — ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS (January 8, 2009)
  • K071455 — ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR (September 11, 2008)
  • K073537 — NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265 (June 27, 2008)
  • K072658 — ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS (April 1, 2008)
  • K072794 — IMMULITE 2500 OM-MA, MODEL L5KOP (November 5, 2007)
  • K071466 — DCA VANTAGE, MODEL 5075 (October 9, 2007)
  • K072204 — ADVIA CHEMISTRY MICROALBUMIN CALIBRATORS, _2 CALIBRATORS (October 5, 2007)
  • K070727 — ADVIA CHEMISTRY ENZYMATIC CREATININE_2 (August 3, 2007)
  • K071017 — IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5 (May 2, 2007)

Other clearances for product code DHB

  • K260280 — NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Cap (June 18, 2026)
  • K260059 — NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excel (May 15, 2026)
  • K252775 — NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Cap (January 16, 2026)
  • K252493 — NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture (December 23, 2025)
  • K242531 — NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum h (April 23, 2025)
  • K212181 — ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Alle (August 3, 2022)
  • K220162 — Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, (February 18, 2022)
  • K193613 — Allergen-Specific IgE Assay 12 Allergen Bundle (October 18, 2021)
  • K200825 — NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; (June 26, 2020)
  • K200279 — ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, (May 1, 2020)

FDA data resources