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 |