The following data is part of a premarket notification filed by Data Medical Associates, Inc. with the FDA for Dma Unsaturated Iron Binding Capacity Procedure.
| Device ID | K946354 |
| 510k Number | K946354 |
| Device Name: | DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE |
| Classification | Ferrozine (colorimetric) Iron Binding Capacity |
| 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 | JMO |
| CFR Regulation Number | 862.1415 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-30 |
| Decision Date | 1995-05-08 |