Cleared Traditional

API UNISCEPT (TM) KB

K864891 · Analytical Products, Inc. · Microbiology
Feb 1987
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K864891 is an FDA 510(k) clearance for the API UNISCEPT (TM) KB, 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 February 20, 1987, 67 days after receiving the submission on December 15, 1986. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K864891 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 1986
Decision Date February 20, 1987
Days to Decision 67 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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