The following data is part of a premarket notification filed by Data Medical Associates, Inc. with the FDA for Dma Ld Kinetic Procedure.
| Device ID | K915803 |
| 510k Number | K915803 |
| Device Name: | DMA LD KINETIC PROCEDURE |
| Classification | Nad Reduction/nadh Oxidation, Lactate Dehydrogenase |
| 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 | CFJ |
| CFR Regulation Number | 862.1440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-24 |
| Decision Date | 1992-03-18 |