Cleared Traditional

STREPTOLEX-STAT

K962296 · Unipath , Ltd. · Microbiology
Dec 1996
Decision
187d
Days
Class 1
Risk

About This 510(k) Submission

K962296 is an FDA 510(k) clearance for the STREPTOLEX-STAT, a Antisera, All Groups, Streptococcus Spp. (Class I — General Controls, product code GTZ), submitted by Unipath , Ltd. (Beverly, US). The FDA issued a Cleared decision on December 16, 1996, 187 days after receiving the submission on June 12, 1996. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number K962296 FDA.gov
FDA Decision Cleared SESE
Date Received June 12, 1996
Decision Date December 16, 1996
Days to Decision 187 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

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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