Cleared Traditional

K875180 - V-TREND RPRL CARD TEST
(FDA 510(k) Clearance)

K875180 · Texas Immunology, Inc. · Microbiology

Feb 1988

Decision

49d

Days

Class 2

Risk

K875180 is an FDA 510(k) clearance for the V-TREND RPRL CARD TEST, a Antisera, Control For Nontreponemal Tests (Class II — Special Controls, product code GMP), submitted by Texas Immunology, Inc. (Tyler, US). The FDA issued a Cleared decision on February 4, 1988, 49 days after receiving the submission on December 17, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3820.

Submission Details

510(k) Number	K875180 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 17, 1987
Decision Date	February 04, 1988
Days to Decision	49 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—