Cleared Special

BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A

K082661 · Princeton BioMeditech Corp. · Microbiology
Oct 2008
Decision
24d
Days
Class 1
Risk

About This 510(k) Submission

K082661 is an FDA 510(k) clearance for the BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A, a Antigens, All Groups, Streptococcus Spp. (Class I — General Controls, product code GTY), submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on October 6, 2008, 24 days after receiving the submission on September 12, 2008. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number K082661 FDA.gov
FDA Decision Cleared SESE
Date Received September 12, 2008
Decision Date October 06, 2008
Days to Decision 24 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Statement

Device Classification

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

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