The following data is part of a premarket notification filed by Data Medical Associates, Inc. with the FDA for Amylase Colorimetric Procedure.
Device ID | K864825 |
510k Number | K864825 |
Device Name: | AMYLASE COLORIMETRIC PROCEDURE |
Classification | Catalytic Methods, Amylase |
Applicant | DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington, TX 76011 |
Contact | Marjorie B Potts |
Correspondent | Marjorie B Potts DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington, TX 76011 |
Product Code | JFJ |
CFR Regulation Number | 862.1070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-12-09 |
Decision Date | 1987-02-20 |