The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for Glucose (hexokinase) Liquid Reagent, Model G518-150.
| Device ID | K000102 |
| 510k Number | K000102 |
| Device Name: | GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150 |
| Classification | Hexokinase, Glucose |
| Applicant | TECO DIAGNOSTICS 4925 EAST HUNTER AVE. Anaheim, CA 92807 |
| Contact | Dindo Carrillo |
| Correspondent | Dindo Carrillo TECO DIAGNOSTICS 4925 EAST HUNTER AVE. Anaheim, CA 92807 |
| Product Code | CFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-13 |
| Decision Date | 2000-02-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10673486001686 | K000102 | 000 |
| 10673486001662 | K000102 | 000 |
| 00850053916113 | K000102 | 000 |