Cleared Traditional

K841174 - RUBELLA ANTIBODY FLUOROIMMUNOASSAY
(FDA 510(k) Clearance)

K841174 · Intl. Diagnostic Technology · Microbiology

Jun 1984

Decision

80d

Days

Class 2

Risk

K841174 is an FDA 510(k) clearance for the RUBELLA ANTIBODY FLUOROIMMUNOASSAY. This device is classified as a Antigen, Ha (including Ha Control), Rubella (Class II — Special Controls, product code GOL).

Submitted by Intl. Diagnostic Technology (Walker, US). The FDA issued a Cleared decision on June 7, 1984, 80 days after receiving the submission on March 19, 1984.

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

Submission Details

510(k) Number	K841174 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 19, 1984
Decision Date	June 07, 1984
Days to Decision	80 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—