Cleared Traditional

PHARMACIA DELFIA SYSTEM B2-MICRO

K903578 · Pharmacia, Inc. · Immunology
Aug 1990
Decision
9d
Days
Class 2
Risk

About This 510(k) Submission

K903578 is an FDA 510(k) clearance for the PHARMACIA DELFIA SYSTEM B2-MICRO, 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 August 17, 1990, 9 days after receiving the submission on August 8, 1990. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5630.

Submission Details

510(k) Number K903578 FDA.gov
FDA Decision Cleared SESE
Date Received August 08, 1990
Decision Date August 17, 1990
Days to Decision 9 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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