The following data is part of a premarket notification filed by Trace Scientific Ltd. with the FDA for Enzymatic Glucose Reagent Single Vial Glucose Oxid.
| Device ID | K860726 |
| 510k Number | K860726 |
| Device Name: | ENZYMATIC GLUCOSE REAGENT SINGLE VIAL GLUCOSE OXID |
| Classification | Glucose Dehydrogenase, Glucose |
| Applicant | TRACE SCIENTIFIC LTD. 10 TREFOREST DR. Clayton, Vic 3168, AU |
| Contact | W. C Riddle |
| Correspondent | W. C Riddle TRACE SCIENTIFIC LTD. 10 TREFOREST DR. Clayton, Vic 3168, AU |
| Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-26 |
| Decision Date | 1986-04-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845275002409 | K860726 | 000 |