The following data is part of a premarket notification filed by Data Medical Associates, Inc. with the FDA for Dma Amylase Procedure.
Device ID | K931559 |
510k Number | K931559 |
Device Name: | DMA AMYLASE PROCEDURE |
Classification | Starch-dye Bound Polymer, Amylase |
Applicant | DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington, TX 76011 |
Contact | Annette Wells |
Correspondent | Annette Wells DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington, TX 76011 |
Product Code | CIW |
CFR Regulation Number | 862.1070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-30 |
Decision Date | 1993-10-28 |