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510(k) K851512

ALLERGENETICS IGE FAST TEST by Allergenetics — Product Code DHB

K851512 is an FDA 510(k) premarket notification submitted by Allergenetics for the device "ALLERGENETICS IGE FAST TEST". The FDA issued a decision of Substantially Equivalent on May 28, 1985. The device falls under product code DHB (System, Test, Radioallergosorbent (Rast) Immunological), a Class II device regulated under 21 CFR 866.5750. Allergenetics has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1985
Date Received
April 15, 1985
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 Allergenetics

  • K842970 — ALLERGENTICS TOTAL IGE/THEOPHYLLINE (August 29, 1984)
  • K842969 — ALLERGENETICS ALLER-SPECIFIC IGE SERUM (August 28, 1984)
  • K833418 — CHYMOFAST TEST (March 12, 1984)
  • K834594 — TOTAL IGE FAST TEST (February 10, 1984)
  • K833419 — LABELED 125I ANTI-IGE (February 3, 1984)
  • K834244 — THEOFAST TEST KIT FOR QUANTITATIVE THEO (January 24, 1984)
  • K822341 — ALLERGENETICS IGE-FAST TEST (November 10, 1982)

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