Cleared Traditional

RUBELISA TEST KIT

K780996 · Microbiological Assoc. · Microbiology

Nov 1978

Decision

162d

Days

Class 2

Risk

About This 510(k) Submission

K780996 is an FDA 510(k) clearance for the RUBELISA TEST KIT, a Antigen, Cf (including Cf Control), Rubella (Class II — Special Controls, product code GON), submitted by Microbiological Assoc. (Mchenry, US). The FDA issued a Cleared decision on November 22, 1978, 162 days after receiving the submission on June 13, 1978. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number	K780996 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 13, 1978
Decision Date	November 22, 1978
Days to Decision	162 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—