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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Heparin
510(k) Number K972209
Device Name SPECTROLYSE HEPARIN (ANTI-IIA)
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 Number864.7525
Classification Product Code
KFF  
Date Received06/11/1997
Decision Date 08/12/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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