Cleared Traditional

RUBELLA ELISA REAGENTS RUBELLA IGG ANTI

K802102 · Calbiochem-Behring Corp. · Immunology
Dec 1980
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K802102 is an FDA 510(k) clearance for the RUBELLA ELISA REAGENTS RUBELLA IGG ANTI, a Antigen, Ha (including Ha Control), Rubella (Class II — Special Controls, product code GOL), submitted by Calbiochem-Behring Corp. (Mchenry, US). The FDA issued a Cleared decision on December 18, 1980, 106 days after receiving the submission on September 3, 1980. This device falls under the Immunology review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number K802102 FDA.gov
FDA Decision Cleared SESE
Date Received September 03, 1980
Decision Date December 18, 1980
Days to Decision 106 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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