Cleared Traditional

API UNISCEPT MIC/TYPE 2 AND 3 AND MICRO MIC

K923684 · Analytical Products, Inc. · Microbiology
Dec 1992
Decision
133d
Days
Class 2
Risk

About This 510(k) Submission

K923684 is an FDA 510(k) clearance for the API UNISCEPT MIC/TYPE 2 AND 3 AND MICRO MIC, a Manual Antimicrobial Susceptibility Test Systems (Class II — Special Controls, product code JWY), submitted by Analytical Products, Inc. (Plainview, US). The FDA issued a Cleared decision on December 3, 1992, 133 days after receiving the submission on July 23, 1992. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K923684 FDA.gov
FDA Decision Cleared SESE
Date Received July 23, 1992
Decision Date December 03, 1992
Days to Decision 133 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code JWY — Manual Antimicrobial Susceptibility Test Systems
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1640

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