The following data is part of a premarket notification filed by Tech-co, Inc. with the FDA for Glucose (hexokinase).
| Device ID | K874846 |
| 510k Number | K874846 |
| Device Name: | GLUCOSE (HEXOKINASE) |
| Classification | Hexokinase, Glucose |
| Applicant | TECH-CO, INC. 24111 BEVERLY Oak Park, MI 48237 |
| Contact | Happy Chen |
| Correspondent | Happy Chen TECH-CO, INC. 24111 BEVERLY Oak Park, MI 48237 |
| Product Code | CFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-24 |
| Decision Date | 1988-03-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10673486001709 | K874846 | 000 |
| 10673486001693 | K874846 | 000 |