Cleared Traditional

RUBELLA ANTIBODIES TEST REAGENTS

K810309 · Calbiochem-Behring Corp. · Immunology
Mar 1981
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K810309 is an FDA 510(k) clearance for the RUBELLA ANTIBODIES TEST REAGENTS, a Antigen, Ha (including Ha Control), Rubella (Class II — Special Controls, product code GOL), submitted by Calbiochem-Behring Corp. (Walker, US). The FDA issued a Cleared decision on March 11, 1981, 34 days after receiving the submission on February 5, 1981. This device falls under the Immunology review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number K810309 FDA.gov
FDA Decision Cleared SESE
Date Received February 05, 1981
Decision Date March 11, 1981
Days to Decision 34 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code GOL — Antigen, Ha (including Ha Control), Rubella
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3510

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