The following data is part of a premarket notification filed by Biochemical Trade, Inc. with the FDA for Gamma-glutamyl Transferase Determination.
Device ID | K905649 |
510k Number | K905649 |
Device Name: | GAMMA-GLUTAMYL TRANSFERASE DETERMINATION |
Classification | Kinetic Method, Gamma-glutamyl Transpeptidase |
Applicant | BIOCHEMICAL TRADE, INC. 7522 N.W. 55TH ST. Miami, FL 33166 |
Contact | Alejo V Roy |
Correspondent | Alejo V Roy BIOCHEMICAL TRADE, INC. 7522 N.W. 55TH ST. Miami, FL 33166 |
Product Code | JQB |
CFR Regulation Number | 862.1360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-12-18 |
Decision Date | 1991-01-30 |