Cleared Traditional

K980912 - VCA IGG ELISA TEST SYSTEM
(FDA 510(k) Clearance)

K980912 · Clark Laboratories, Inc. · Microbiology

Jul 1998

Decision

134d

Days

Class 1

Risk

K980912 is an FDA 510(k) clearance for the VCA IGG ELISA TEST SYSTEM. This device is classified as a Epstein-barr Virus, Other (Class I — General Controls, product code LSE).

Submitted by Clark Laboratories, Inc. (Frederick, US). The FDA issued a Cleared decision on July 22, 1998, 134 days after receiving the submission on March 10, 1998.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3235.

Submission Details

510(k) Number	K980912 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 10, 1998
Decision Date	July 22, 1998
Days to Decision	134 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF