COAMATE PROTEIN C CHROMOGENIC ASSAY

Test, Qualitative And Quantitative Factor Deficiency

CHROMOGENIX AB

The following data is part of a premarket notification filed by Chromogenix Ab with the FDA for Coamate Protein C Chromogenic Assay.

Pre-market Notification Details

Device IDK922201
510k NumberK922201
Device Name:COAMATE PROTEIN C CHROMOGENIC ASSAY
ClassificationTest, Qualitative And Quantitative Factor Deficiency
Applicant CHROMOGENIX AB TALJEGARDSGATAN 3 Molndal,  SE S-431 53
ContactLeif Aurell
CorrespondentLeif Aurell
CHROMOGENIX AB TALJEGARDSGATAN 3 Molndal,  SE S-431 53
Product CodeGGP  
CFR Regulation Number864.7290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-05-11
Decision Date1992-12-07

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08426950088875 K922201 000

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