Cleared Traditional

API UNISCEPT KB/TYPE 2 AND 3

K922926 · Analytical Products, Inc. · Microbiology
Oct 1992
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K922926 is an FDA 510(k) clearance for the API UNISCEPT KB/TYPE 2 AND 3, 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 October 13, 1992, 118 days after receiving the submission on June 17, 1992. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K922926 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 1992
Decision Date October 13, 1992
Days to Decision 118 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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