RHEUMOGEN TEST SYSTEM

System, Test, Rheumatoid Factor

CALBIOCHEM-BEHRING CORP.

The following data is part of a premarket notification filed by Calbiochem-behring Corp. with the FDA for Rheumogen Test System.

Pre-market Notification Details

Device IDK790012
510k NumberK790012
Device Name:RHEUMOGEN TEST SYSTEM
ClassificationSystem, Test, Rheumatoid Factor
Applicant CALBIOCHEM-BEHRING CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDHR  
CFR Regulation Number866.5775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-01-02
Decision Date1979-01-26

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