Cleared Traditional

STREP A OIA

K915758 · Biosearch Medical Products, Inc. · Microbiology
Jan 1992
Decision
38d
Days
Class 1
Risk

About This 510(k) Submission

K915758 is an FDA 510(k) clearance for the STREP A OIA, a Antisera, All Groups, Streptococcus Spp. (Class I — General Controls, product code GTZ), submitted by Biosearch Medical Products, Inc. (Boulder, US). The FDA issued a Cleared decision on January 30, 1992, 38 days after receiving the submission on December 23, 1991. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number K915758 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 1991
Decision Date January 30, 1992
Days to Decision 38 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code GTZ — Antisera, All Groups, Streptococcus Spp.
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3740

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