The following data is part of a premarket notification filed by Data Medical Associates, Inc. with the FDA for Dma Glucose (oxidase) Procedure.
| Device ID | K943241 |
| 510k Number | K943241 |
| Device Name: | DMA GLUCOSE (OXIDASE) PROCEDURE |
| Classification | Glucose Oxidase, Glucose |
| Applicant | DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington, TX 76011 |
| Contact | Annette T Wells |
| Correspondent | Annette T Wells DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington, TX 76011 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-06 |
| Decision Date | 1994-10-20 |