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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Controls (Assayed And Unassayed)
510(k) Number K965169
Device Name STABLELIN ENZYME LINEARITY TEST SET C (ITEM NO. 003)
Applicant
Specialized Assays, Inc.
P.O. Box 60
Pipersville,  PA  18947
Applicant Contact RICHARD A KAUFMAN
Correspondent
Specialized Assays, Inc.
P.O. Box 60
Pipersville,  PA  18947
Correspondent Contact RICHARD A KAUFMAN
Regulation Number862.1660
Classification Product Code
JJT  
Date Received12/24/1996
Decision Date 02/06/1997
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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