The following data is part of a premarket notification filed by Trace Scientific Ltd. with the FDA for Ld1 Isoenzyme Reagent Kit.
| Device ID | K890996 |
| 510k Number | K890996 |
| Device Name: | LD1 ISOENZYME REAGENT KIT |
| Classification | Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes |
| Applicant | TRACE SCIENTIFIC LTD. 10 TREFOREST DR. Clayton, Vic 3168, AU |
| Contact | P. J Ruthven |
| Correspondent | P. J Ruthven TRACE SCIENTIFIC LTD. 10 TREFOREST DR. Clayton, Vic 3168, AU |
| Product Code | JGF |
| CFR Regulation Number | 862.1445 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-27 |
| Decision Date | 1989-05-05 |