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510(k) K941993

PHARMACIA CAP SYSTEM PHADIATOP FEIA by Pharmacia, Inc. — Product Code DHB

K941993 is an FDA 510(k) premarket notification submitted by Pharmacia, Inc. for the device "PHARMACIA CAP SYSTEM PHADIATOP FEIA". The FDA issued a decision of Substantially Equivalent on January 30, 1996. The device falls under product code DHB (System, Test, Radioallergosorbent (Rast) Immunological), a Class II device regulated under 21 CFR 866.5750. Pharmacia, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1996
Date Received
April 25, 1994
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 Pharmacia, Inc.

  • K974350 — ALLERGAN IMMUNO CAP M4, M8, K70 (February 9, 1998)
  • K972364 — UNICAP PHADIATOP (September 4, 1997)
  • K972068 — UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82 (July 3, 1997)
  • K970420 — MASTERCAP AM 5.0/MASTERCAP RM 5.0 (June 30, 1997)
  • K964152 — UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH (April 23, 1997)
  • K962274 — UNICAP 100 (September 12, 1996)
  • K954337 — GENOTROPIN MIXER (November 13, 1995)
  • K951025 — PISTON SYRINGE (October 19, 1995)
  • K952025 — ROBOCAP (July 26, 1995)
  • K911903 — ALLERGANS PHARMACIA CAP SYS.RAST RIA/FEIA (August 12, 1991)

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