The following data is part of a premarket notification filed by Data Medical Associates, Inc. with the FDA for Gamma Glutamyl Transferase Procedure.
Device ID | K863586 |
510k Number | K863586 |
Device Name: | GAMMA GLUTAMYL TRANSFERASE PROCEDURE |
Classification | Colorimetric Method, Gamma-glutamyl Transpeptidase |
Applicant | DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington, TX 76011 |
Contact | Marjorie B Potts |
Correspondent | Marjorie B Potts DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington, TX 76011 |
Product Code | JPZ |
CFR Regulation Number | 862.1360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-09-15 |
Decision Date | 1986-10-03 |