Cleared Traditional

K854852 - WELLCOGEN BACTERIAL ANTIGEN KIT
(FDA 510(k) Clearance)

K854852 · Wellcome Diagnostics · Microbiology

Feb 1986

Decision

61d

Days

Class 2

Risk

K854852 is an FDA 510(k) clearance for the WELLCOGEN BACTERIAL ANTIGEN KIT, a Antisera, All Groups, N. Meningitidis (Class II — Special Controls, product code GTJ), submitted by Wellcome Diagnostics (Research Triangle Pk, US). The FDA issued a Cleared decision on February 4, 1986, 61 days after receiving the submission on December 5, 1985. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3390.

Submission Details

510(k) Number	K854852 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 05, 1985
Decision Date	February 04, 1986
Days to Decision	61 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—