Cleared Traditional

K801667 - GAMMA COAT(125 I) RUBELLA ANTIBODY
(FDA 510(k) Clearance)

K801667 · Clinical Assays, Inc. · Microbiology

Oct 1980

Decision

94d

Days

Class 2

Risk

K801667 is an FDA 510(k) clearance for the GAMMA COAT(125 I) RUBELLA ANTIBODY. This device is classified as a Antigen, Ha (including Ha Control), Rubella (Class II — Special Controls, product code GOL).

Submitted by Clinical Assays, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 23, 1980, 94 days after receiving the submission on July 21, 1980.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number	K801667 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 21, 1980
Decision Date	October 23, 1980
Days to Decision	94 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—