Cleared Traditional

K874466 - API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT MIC
(FDA 510(k) Clearance)

K874466 · Analytical Products, Inc. · Microbiology
Dec 1987
Decision
37d
Days
Class 2
Risk

K874466 is an FDA 510(k) clearance for the API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT 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 9, 1987, 37 days after receiving the submission on November 2, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K874466 FDA.gov
FDA Decision Cleared SESE
Date Received November 02, 1987
Decision Date December 09, 1987
Days to Decision 37 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

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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