Cleared Traditional

K904652 - LYME STAT M TEST KIT
(FDA 510(k) Clearance)

K904652 · Whittaker Bioproducts, Inc. · Microbiology

Oct 1991

Decision

371d

Days

Class 2

Risk

K904652 is an FDA 510(k) clearance for the LYME STAT M TEST KIT, a Reagent, Borrelia Serological Reagent (Class II — Special Controls, product code LSR), submitted by Whittaker Bioproducts, Inc. (Walkersville, US). The FDA issued a Cleared decision on October 21, 1991, 371 days after receiving the submission on October 15, 1990. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number	K904652 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 15, 1990
Decision Date	October 21, 1991
Days to Decision	371 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—