AMYLASE COLORIMETRIC PROCEDURE

Catalytic Methods, Amylase

DATA MEDICAL ASSOCIATES, INC.

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

Pre-market Notification Details

Device IDK864825
510k NumberK864825
Device Name:AMYLASE COLORIMETRIC PROCEDURE
ClassificationCatalytic Methods, Amylase
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 CodeJFJ  
CFR Regulation Number862.1070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-12-09
Decision Date1987-02-20

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