Cleared Traditional

CULTURETTE BRAND 10-MINUTE GROUP A STREP I.D.

K853073 · Marion Laboratories, Inc. · Microbiology
Aug 1985
Decision
9d
Days
Class 1
Risk

About This 510(k) Submission

K853073 is an FDA 510(k) clearance for the CULTURETTE BRAND 10-MINUTE GROUP A STREP I.D., a Antisera, All Groups, Streptococcus Spp. (Class I — General Controls, product code GTZ), submitted by Marion Laboratories, Inc. (Kansas City, US). The FDA issued a Cleared decision on August 1, 1985, 9 days after receiving the submission on July 23, 1985. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number K853073 FDA.gov
FDA Decision Cleared SESE
Date Received July 23, 1985
Decision Date August 01, 1985
Days to Decision 9 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

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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