Cleared Traditional

PHARMACIA SPECIFIC IGE CONTROL

K911631 · Pharmacia, Inc. · Immunology
Apr 1991
Decision
13d
Days
Class 2
Risk

About This 510(k) Submission

K911631 is an FDA 510(k) clearance for the PHARMACIA SPECIFIC IGE CONTROL, a Ige, Antigen, Antiserum, Control (Class II — Special Controls, product code DGC), submitted by Pharmacia, Inc. (New Brunswick, US). The FDA issued a Cleared decision on April 24, 1991, 13 days after receiving the submission on April 11, 1991. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K911631 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 1991
Decision Date April 24, 1991
Days to Decision 13 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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