The following data is part of a premarket notification filed by Data Medical Associates, Inc. with the FDA for Ggt Procedure Or Gamma Glutamyl Transferase Proced.
Device ID | K844720 |
510k Number | K844720 |
Device Name: | GGT PROCEDURE OR GAMMA GLUTAMYL TRANSFERASE PROCED |
Classification | Kinetic Method, Gamma-glutamyl Transpeptidase |
Applicant | DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington, TX 76011 |
Contact | Jerry A Graham |
Correspondent | Jerry A Graham DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington, TX 76011 |
Product Code | JQB |
CFR Regulation Number | 862.1360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-12-04 |
Decision Date | 1984-12-12 |