Cleared Traditional

PHARMACIA B2 MICRO EIA

K900449 · Pharmacia, Inc. · Immunology
Feb 1990
Decision
6d
Days
Class 2
Risk

About This 510(k) Submission

K900449 is an FDA 510(k) clearance for the PHARMACIA B2 MICRO EIA, a System, Test, Beta-2-microglobulin Immunological (Class II — Special Controls, product code JZG), submitted by Pharmacia, Inc. (Piscataway, US). The FDA issued a Cleared decision on February 5, 1990, 6 days after receiving the submission on January 30, 1990. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5630.

Submission Details

510(k) Number K900449 FDA.gov
FDA Decision Cleared SESE
Date Received January 30, 1990
Decision Date February 05, 1990
Days to Decision 6 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code JZG — System, Test, Beta-2-microglobulin Immunological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5630

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