Cleared Traditional

UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82

K972068 · Pharmacia, Inc. · Immunology
Jul 1997
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K972068 is an FDA 510(k) clearance for the UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82, a System, Test, Radioallergosorbent (rast) Immunological (Class II — Special Controls, product code DHB), submitted by Pharmacia, Inc. (Westervillle, US). The FDA issued a Cleared decision on July 3, 1997, 30 days after receiving the submission on June 3, 1997. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5750.

Submission Details

510(k) Number K972068 FDA.gov
FDA Decision Cleared SESE
Date Received June 03, 1997
Decision Date July 03, 1997
Days to Decision 30 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DHB — System, Test, Radioallergosorbent (rast) Immunological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5750

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