The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Glucose Reagent (hexohinase).
| Device ID | K771311 |
| 510k Number | K771311 |
| Device Name: | GLUCOSE REAGENT (HEXOHINASE) |
| Classification | Hexokinase, Glucose |
| Applicant | MALLINCKRODT CRITICAL CARE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-07-18 |
| Decision Date | 1977-08-03 |