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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 K952768
Device Name ALKPHASE-B ASSAY KIT
Applicant
Metra Biosystems, Inc.
14900 Sweitzer Ln.
Suite 200
Laurel,  MD  20707
Applicant Contact GREG SHIPP
Correspondent
Metra Biosystems, Inc.
14900 Sweitzer Ln.
Suite 200
Laurel,  MD  20707
Correspondent Contact GREG SHIPP
Regulation Number862.1050
Classification Product Code
CIN  
Date Received06/14/1995
Decision Date 08/24/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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