Cleared Traditional

K905257 - OPUS CMV TEST SYSTEM
(FDA 510(k) Clearance)

K905257 · Pb Diagnostic Systems, Inc. · Microbiology

Apr 1991

Decision

147d

Days

Class 2

Risk

K905257 is an FDA 510(k) clearance for the OPUS CMV TEST SYSTEM. This device is classified as a Antisera, Conjugated Fluorescent, Cytomegalovirus (Class II — Special Controls, product code LIN).

Submitted by Pb Diagnostic Systems, Inc. (Westwood, US). The FDA issued a Cleared decision on April 17, 1991, 147 days after receiving the submission on November 21, 1990.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number	K905257 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 21, 1990
Decision Date	April 17, 1991
Days to Decision	147 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—