The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Dart Gamma-gt Reagent System.
| Device ID | K834054 |
| 510k Number | K834054 |
| Device Name: | DART GAMMA-GT REAGENT SYSTEM |
| Classification | Kinetic Method, Gamma-glutamyl Transpeptidase |
| Applicant | COULTER ELECTRONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JQB |
| CFR Regulation Number | 862.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-23 |
| Decision Date | 1984-02-04 |