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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
510(k) Number K880307
Device Name ALKALINE PHOSPHATASE REAGENT SET
Applicant
Tech-Neal Scientific, Inc.
817 Oakwood Dr.
Westmont,  IL  60559
Applicant Contact ARUN SANGHAVI
Correspondent
Tech-Neal Scientific, Inc.
817 Oakwood Dr.
Westmont,  IL  60559
Correspondent Contact ARUN SANGHAVI
Regulation Number862.1050
Classification Product Code
CJE  
Date Received01/25/1988
Decision Date 03/15/1988
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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