DMA AMYLASE PROCEDURE

Starch-dye Bound Polymer, Amylase

DATA MEDICAL ASSOCIATES, INC.

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

Pre-market Notification Details

Device IDK931559
510k NumberK931559
Device Name:DMA AMYLASE PROCEDURE
ClassificationStarch-dye Bound Polymer, Amylase
Applicant DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington,  TX  76011
ContactAnnette Wells
CorrespondentAnnette Wells
DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington,  TX  76011
Product CodeCIW  
CFR Regulation Number862.1070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-03-30
Decision Date1993-10-28

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