The following data is part of a premarket notification filed by Data Medical Associates, Inc. with the FDA for Lithium Concentrate For A Flame Photometer.
Device ID | K895718 |
510k Number | K895718 |
Device Name: | LITHIUM CONCENTRATE FOR A FLAME PHOTOMETER |
Classification | Flame Photometry, Potassium |
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 | JGM |
CFR Regulation Number | 862.1600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-09-25 |
Decision Date | 1989-10-19 |