The following data is part of a premarket notification filed by Tech-neal Scientific, Inc. with the FDA for Glucose Hexokinase.
| Device ID | K880236 |
| 510k Number | K880236 |
| Device Name: | GLUCOSE HEXOKINASE |
| Classification | Hexokinase, Glucose |
| Applicant | TECH-NEAL SCIENTIFIC, INC. 817 OAKWOOD DR. Westmont, IL 60559 |
| Contact | Arun Sanghavi |
| Correspondent | Arun Sanghavi TECH-NEAL SCIENTIFIC, INC. 817 OAKWOOD DR. Westmont, IL 60559 |
| Product Code | CFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-20 |
| Decision Date | 1988-03-15 |