Cleared Traditional

VISUWELL REAGIN TEST 960 TEST KIT

K885298 · Allelix Diagnostics, Inc. · Microbiology

Mar 1989

Decision

78d

Days

Class 2

Risk

About This 510(k) Submission

K885298 is an FDA 510(k) clearance for the VISUWELL REAGIN TEST 960 TEST KIT, a Antisera, Control For Nontreponemal Tests (Class II — Special Controls, product code GMP), submitted by Allelix Diagnostics, Inc. (Canada L4v 1p1, CA). The FDA issued a Cleared decision on March 15, 1989, 78 days after receiving the submission on December 27, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3820.

Submission Details

510(k) Number	K885298 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 27, 1988
Decision Date	March 15, 1989
Days to Decision	78 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—