Cleared Traditional

UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH

K964152 · Pharmacia, Inc. · Immunology
Apr 1997
Decision
189d
Days
Class 2
Risk

About This 510(k) Submission

K964152 is an FDA 510(k) clearance for the UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH, a Ige, Antigen, Antiserum, Control (Class II — Special Controls, product code DGC), submitted by Pharmacia, Inc. (Westervillle, US). The FDA issued a Cleared decision on April 23, 1997, 189 days after receiving the submission on October 16, 1996. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K964152 FDA.gov
FDA Decision Cleared SESE
Date Received October 16, 1996
Decision Date April 23, 1997
Days to Decision 189 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

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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