Cleared Traditional

K801963 - CMV TEST KIT
(FDA 510(k) Clearance)

K801963 · Immuno-Diagnostic Products, Inc. · Microbiology

Oct 1980

Decision

65d

Days

Class 2

Risk

K801963 is an FDA 510(k) clearance for the CMV TEST KIT. This device is classified as a Antigen, Cf (including Cf Control), Cytomegalovirus (Class II — Special Controls, product code GQH).

Submitted by Immuno-Diagnostic Products, Inc. (Walker, US). The FDA issued a Cleared decision on October 23, 1980, 65 days after receiving the submission on August 19, 1980.

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

Submission Details

510(k) Number	K801963 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 19, 1980
Decision Date	October 23, 1980
Days to Decision	65 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—