Cleared Traditional

K802508 - RUBELISA IGM TEST KIT
(FDA 510(k) Clearance)

K802508 · M.A. Bioproducts · Microbiology

Dec 1980

Decision

64d

Days

Class 2

Risk

K802508 is an FDA 510(k) clearance for the RUBELISA IGM TEST KIT. This device is classified as a Antigen, Ha (including Ha Control), Rubella (Class II — Special Controls, product code GOL).

Submitted by M.A. Bioproducts (Walker, US). The FDA issued a Cleared decision on December 18, 1980, 64 days after receiving the submission on October 15, 1980.

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

Submission Details

510(k) Number	K802508 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 15, 1980
Decision Date	December 18, 1980
Days to Decision	64 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—