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 IDK863268
510k NumberK863268
Device Name:ALKALINE PHOSPHATASE PROCEDURE
ClassificationNitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Applicant DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington,  TX  76011
ContactMarjorie B Potts
CorrespondentMarjorie B Potts
DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington,  TX  76011
Product CodeCJE  
CFR Regulation Number862.1050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-08-25
Decision Date1986-09-29

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.