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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Qualitative And Quantitative Factor Deficiency
510(k) Number K922201
Device Name COAMATE PROTEIN C CHROMOGENIC ASSAY
Applicant
Chromogenix AB
Taljegardsgatan 3
Molndal,  SE S-431 53
Applicant Contact LEIF AURELL
Correspondent
Chromogenix AB
Taljegardsgatan 3
Molndal,  SE S-431 53
Correspondent Contact LEIF AURELL
Regulation Number864.7290
Classification Product Code
GGP  
Date Received05/11/1992
Decision Date 12/07/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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