Cleared Traditional

TARGET STREP A

K880460 · V-Tech, Inc. · Microbiology
Mar 1988
Decision
29d
Days
Class 1
Risk

About This 510(k) Submission

K880460 is an FDA 510(k) clearance for the TARGET STREP A, a Antisera, All Groups, Streptococcus Spp. (Class I — General Controls, product code GTZ), submitted by V-Tech, Inc. (Pomona, US). The FDA issued a Cleared decision on March 3, 1988, 29 days after receiving the submission on February 3, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number K880460 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 1988
Decision Date March 03, 1988
Days to Decision 29 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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