Cleared Traditional

K875101 - VIROGEN CMV ANTIBODY TEST
(FDA 510(k) Clearance)

K875101 · Wampole Laboratories · Microbiology device
Mar 1988
Decision
82d
Days
Class 1
Risk

K875101 is an FDA 510(k) clearance for the VIROGEN CMV ANTIBODY TEST. This device is classified as a Dna-reagents, Campylobacter Spp. (Class I - General Controls, product code LQO).

Submitted by Wampole Laboratories (Cranbury, US). The FDA issued a Cleared decision on March 1, 1988, 82 days after receiving the submission on December 10, 1987.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3110.

Submission Details

510(k) Number K875101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1987
Decision Date March 01, 1988
Days to Decision 82 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code LQO — Dna-reagents, Campylobacter Spp.
Device Class Class I - General Controls
CFR Regulation 21 CFR 866.3110