Cleared Traditional

INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC

K051638 · Unipath , Ltd. · Microbiology
Dec 2005
Decision
169d
Days
Class 1
Risk

About This 510(k) Submission

K051638 is an FDA 510(k) clearance for the INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC, a Antigens, All Groups, Streptococcus Spp. (Class I — General Controls, product code GTY), submitted by Unipath , Ltd. (Bedford, GB). The FDA issued a Cleared decision on December 6, 2005, 169 days after receiving the submission on June 20, 2005. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number K051638 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 2005
Decision Date December 06, 2005
Days to Decision 169 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

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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