Cleared Traditional

K850347 - API UNISCEPT KB
(FDA 510(k) Clearance)

K850347 · Analytical Products, Inc. · Microbiology

Mar 1985

Decision

57d

Days

Class 2

Risk

K850347 is an FDA 510(k) clearance for the API UNISCEPT KB, a Susceptibility Test Cards, Antimicrobial (Class II — Special Controls, product code LTW), submitted by Analytical Products, Inc. (Plainview, US). The FDA issued a Cleared decision on March 26, 1985, 57 days after receiving the submission on January 28, 1985. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number	K850347 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 28, 1985
Decision Date	March 26, 1985
Days to Decision	57 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—