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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 K962489
Device Name CHROMOLIZE TPA ASSAY KIT
Applicant
Medical Diagnostic Technologies, Inc.
6025 Nicolle St.
Ventura,  CA  93003
Applicant Contact MICHAEL D BICK
Correspondent
Medical Diagnostic Technologies, Inc.
6025 Nicolle St.
Ventura,  CA  93003
Correspondent Contact MICHAEL D BICK
Regulation Number864.7290
Classification Product Code
GGP  
Date Received06/26/1996
Decision Date 07/31/1996
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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