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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 K925617
Device Name MDA PROTEIN ASSAY
Applicant
ORGANON TEKNIKA CORP.
100 AKZO AVE.
DURHAM,  NC  27712
Applicant Contact ANN M QUINN
Correspondent
ORGANON TEKNIKA CORP.
100 AKZO AVE.
DURHAM,  NC  27712
Correspondent Contact ANN M QUINN
Regulation Number864.7290
Classification Product Code
GGP  
Date Received11/06/1992
Decision Date 01/27/1994
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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