The following data is part of a premarket notification filed by Enzyme Technology, Inc. with the FDA for Glucose (hk) Reagent, Universal.
| Device ID | K905227 |
| 510k Number | K905227 |
| Device Name: | GLUCOSE (HK) REAGENT, UNIVERSAL |
| Classification | Hexokinase, Glucose |
| Applicant | ENZYME TECHNOLOGY, INC. 415 HOWE AVE. Shelton, CT 06484 |
| Contact | Peter Klamka |
| Correspondent | Peter Klamka ENZYME TECHNOLOGY, INC. 415 HOWE AVE. Shelton, CT 06484 |
| Product Code | CFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-20 |
| Decision Date | 1991-03-11 |