The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Glutamyl-transferase, Procedure No. 419.
| Device ID | K935984 |
| 510k Number | K935984 |
| Device Name: | GLUTAMYL-TRANSFERASE, PROCEDURE NO. 419 |
| Classification | Kinetic Method, Gamma-glutamyl Transpeptidase |
| Applicant | SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St.louis, MO 63103 |
| Contact | William R Gilbert |
| Correspondent | William R Gilbert SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St.louis, MO 63103 |
| Product Code | JQB |
| CFR Regulation Number | 862.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-14 |
| Decision Date | 1994-07-20 |