The following data is part of a premarket notification filed by Data Medical Associates, Inc. with the FDA for Dma Microprotein Procedure.
Device ID | K942424 |
510k Number | K942424 |
Device Name: | DMA MICROPROTEIN PROCEDURE |
Classification | Biuret (colorimetric), Total Protein |
Applicant | DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington, TX 76011 |
Contact | Regulatory Affairs Person |
Correspondent | Regulatory Affairs Person DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington, TX 76011 |
Product Code | CEK |
CFR Regulation Number | 862.1635 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-05-20 |
Decision Date | 1994-09-06 |