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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 K981373
Device Name ALKPHASE-B ASSAY KIT
Applicant
METRA BIOSYSTEMS, INC.
265 NORTH WHISMAN RD.
MOUNTAIN VIEW,  CA  94043 -3911
Applicant Contact JILL VISOR
Correspondent
METRA BIOSYSTEMS, INC.
265 NORTH WHISMAN RD.
MOUNTAIN VIEW,  CA  94043 -3911
Correspondent Contact JILL VISOR
Regulation Number862.1050
Classification Product Code
CIN  
Date Received04/16/1998
Decision Date 05/27/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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