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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 K963106
Device Name CHROMOLIZE PAI-1 KIT
Applicant
Medical Diagnostic Technologies, Inc.
6025 Nicolle St.
Ventura,  CA  93003
Applicant Contact MICHAEL D BICK, PH.D.
Correspondent
Medical Diagnostic Technologies, Inc.
6025 Nicolle St.
Ventura,  CA  93003
Correspondent Contact MICHAEL D BICK, PH.D.
Regulation Number864.7290
Classification Product Code
GGP  
Date Received08/12/1996
Decision Date 11/18/1996
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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