ALKALINE PHOSPHATASE PROCEDURE

Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

DATA MEDICAL ASSOCIATES, INC.

The following data is part of a premarket notification filed by Data Medical Associates, Inc. with the FDA for Alkaline Phosphatase Procedure.

Pre-market Notification Details

Device IDK861667
510k NumberK861667
Device Name:ALKALINE PHOSPHATASE PROCEDURE
ClassificationNitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Applicant DATA MEDICAL ASSOCIATES, INC. 2016 E. RANDOL MILL RD. Arlington,  TX  70611
ContactJerry A Graham
CorrespondentJerry A Graham
DATA MEDICAL ASSOCIATES, INC. 2016 E. RANDOL MILL RD. Arlington,  TX  70611
Product CodeCJE  
CFR Regulation Number862.1050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-04-30
Decision Date1986-05-29

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