Cleared Traditional

MODIFICATIONS TO API UNISCEPT (R) KB

K880598 · Analytical Products, Inc. · Microbiology
Mar 1988
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K880598 is an FDA 510(k) clearance for the MODIFICATIONS TO API UNISCEPT (R) 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 March 23, 1988, 41 days after receiving the submission on February 11, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K880598 FDA.gov
FDA Decision Cleared SESE
Date Received February 11, 1988
Decision Date March 23, 1988
Days to Decision 41 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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