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FDA 510(k) Application Details - K973588
Device Classification Name
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
More FDA Info for this Device
510(K) Number
K973588
Device Name
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Applicant
POINTE SCIENTIFIC, INC.
1025 JOHN A. PAPALAS DR.
LINCOLN PARK, MI 48146 US
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Contact
WILLIAM F WALTERS
Other 510(k) Applications for this Contact
Regulation Number
862.1050
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Classification Product Code
CJE
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More FDA Info for this Product Code
Date Received
09/22/1997
Decision Date
10/22/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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