ENZYGNOST TM RUBELLA IGM

Enzyme Linked Immunoabsorbent Assay, Rubella

CALBIOCHEM-BEHRING CORP.

The following data is part of a premarket notification filed by Calbiochem-behring Corp. with the FDA for Enzygnost Tm Rubella Igm.

Pre-market Notification Details

Device IDK813493
510k NumberK813493
Device Name:ENZYGNOST TM RUBELLA IGM
ClassificationEnzyme Linked Immunoabsorbent Assay, Rubella
Applicant CALBIOCHEM-BEHRING CORP. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeLFX  
CFR Regulation Number866.3510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-12-14
Decision Date1982-03-04

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