The following data is part of a premarket notification filed by Data Medical Associates, Inc. with the FDA for Dma Triglyceride (gpo) Procedure.
Device ID | K902202 |
510k Number | K902202 |
Device Name: | DMA TRIGLYCERIDE (GPO) PROCEDURE |
Classification | Colorimetric Method, Triglycerides |
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 | JGY |
CFR Regulation Number | 862.1705 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-05-16 |
Decision Date | 1990-07-31 |