Cleared Traditional

READS ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT

K902236 · Biosearch Medical Products, Inc. · Immunology
Aug 1990
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K902236 is an FDA 510(k) clearance for the READS ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, a Test, Time, Partial Thromboplastin (Class II — Special Controls, product code GGW), submitted by Biosearch Medical Products, Inc. (Boulder, US). The FDA issued a Cleared decision on August 14, 1990, 89 days after receiving the submission on May 17, 1990. This device falls under the Immunology review panel. Regulated under 21 CFR 864.7925.

Submission Details

510(k) Number K902236 FDA.gov
FDA Decision Cleared SESE
Date Received May 17, 1990
Decision Date August 14, 1990
Days to Decision 89 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code GGW — Test, Time, Partial Thromboplastin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7925

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