Cleared Traditional

PROTECT T.M.

K871121 · Pro-Lab, Inc. · Microbiology
Apr 1987
Decision
26d
Days
Class 1
Risk

About This 510(k) Submission

K871121 is an FDA 510(k) clearance for the PROTECT T.M., a Kit, Quality Control For Culture Media (Class I — General Controls, product code JTR), submitted by Pro-Lab, Inc. (Scarborough Ont, CA). The FDA issued a Cleared decision on April 14, 1987, 26 days after receiving the submission on March 19, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2480.

Submission Details

510(k) Number K871121 FDA.gov
FDA Decision Cleared SESE
Date Received March 19, 1987
Decision Date April 14, 1987
Days to Decision 26 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JTR — Kit, Quality Control For Culture Media
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2480

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