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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 K973588
Device Name LIQUID ALKALINE PHOSHATASE REAGENT SET
Applicant
POINTE SCIENTIFIC, INC.
1025 JOHN A. PAPALAS DR.
LINCOLN PARK,  MI  48146
Applicant Contact WILLIAM F WALTERS
Correspondent
POINTE SCIENTIFIC, INC.
1025 JOHN A. PAPALAS DR.
LINCOLN PARK,  MI  48146
Correspondent Contact WILLIAM F WALTERS
Regulation Number862.1050
Classification Product Code
CJE  
Date Received09/22/1997
Decision Date 10/22/1997
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
Recalls CDRH Recalls
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