Cleared Traditional

PHARMACIA CAP SYSTEM IGE RIA AND FEIA

K893951 · Pharmacia, Inc. · Immunology
Jul 1989
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K893951 is an FDA 510(k) clearance for the PHARMACIA CAP SYSTEM IGE RIA AND FEIA, a Ige, Antigen, Antiserum, Control (Class II — Special Controls, product code DGC), submitted by Pharmacia, Inc. (Piscataway, US). The FDA issued a Cleared decision on July 14, 1989, 43 days after receiving the submission on June 1, 1989. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K893951 FDA.gov
FDA Decision Cleared SESE
Date Received June 01, 1989
Decision Date July 14, 1989
Days to Decision 43 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code DGC — Ige, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510

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