The following data is part of a premarket notification filed by Data Medical Associates, Inc. with the FDA for Dma Glucose Hexokinase U.v. Procedure.
| Device ID | K952437 |
| 510k Number | K952437 |
| Device Name: | DMA GLUCOSE HEXOKINASE U.V. PROCEDURE |
| Classification | Hexokinase, Glucose |
| Applicant | DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington, TX 76011 |
| Contact | C. H Morris |
| Correspondent | C. H Morris DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington, TX 76011 |
| Product Code | CFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-25 |
| Decision Date | 1995-10-03 |