DATA ZYME ACID PHOSPHATASE PROCEDURE

Acid Phosphatase, Naphthyl Phosphate

DATA MEDICAL ASSOCIATES, INC.

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

Pre-market Notification Details

Device IDK850902
510k NumberK850902
Device Name:DATA ZYME ACID PHOSPHATASE PROCEDURE
ClassificationAcid Phosphatase, Naphthyl Phosphate
Applicant DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington,  TX  76011
ContactJerry A Graham
CorrespondentJerry A Graham
DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington,  TX  76011
Product CodeCKB  
CFR Regulation Number862.1020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-03-05
Decision Date1985-03-20

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