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 |