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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
510(k) Number K961573
Device Name TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY
Applicant
Hybritech, Inc.
P.O. Box 269006
San Diego,  CA  92196
Applicant Contact ISAAC A MIZRAHI
Correspondent
Hybritech, Inc.
P.O. Box 269006
San Diego,  CA  92196
Correspondent Contact ISAAC A MIZRAHI
Regulation Number862.1050
Classification Product Code
CIN  
Date Received04/23/1996
Decision Date 08/19/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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