Cleared Traditional

K844159 - API UNISCEPT MIC 100UL
(FDA 510(k) Clearance)

K844159 · Analytical Products, Inc. · Microbiology

Dec 1984

Decision

51d

Days

Class 2

Risk

K844159 is an FDA 510(k) clearance for the API UNISCEPT MIC 100UL, 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 December 14, 1984, 51 days after receiving the submission on October 24, 1984. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number	K844159 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 24, 1984
Decision Date	December 14, 1984
Days to Decision	51 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—