Cleared Traditional

NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST

K870117 · Pro-Lab, Inc. · Microbiology
Mar 1987
Decision
67d
Days
Class 1
Risk

About This 510(k) Submission

K870117 is an FDA 510(k) clearance for the NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST, a Kit, Identification, Neisseria Gonorrhoeae (Class I — General Controls, product code JSX), submitted by Pro-Lab, Inc. (Scarborough Ont, CA). The FDA issued a Cleared decision on March 20, 1987, 67 days after receiving the submission on January 12, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K870117 FDA.gov
FDA Decision Cleared SESE
Date Received January 12, 1987
Decision Date March 20, 1987
Days to Decision 67 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JSX — Kit, Identification, Neisseria Gonorrhoeae
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660