Cleared Traditional

OIA STREP A

K912889 · Biosearch Medical Products, Inc. · Microbiology
Oct 1991
Decision
122d
Days
Class 1
Risk

About This 510(k) Submission

K912889 is an FDA 510(k) clearance for the OIA STREP A, 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 October 31, 1991, 122 days after receiving the submission on July 1, 1991. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number K912889 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 1991
Decision Date October 31, 1991
Days to Decision 122 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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