The following data is part of a premarket notification filed by Simmler, Inc. with the FDA for Multichem Glucose Hexokinase Reagent #s0919.
| Device ID | K871976 |
| 510k Number | K871976 |
| Device Name: | MULTICHEM GLUCOSE HEXOKINASE REAGENT #S0919 |
| Classification | Hexokinase, Glucose |
| Applicant | SIMMLER, INC. POST OFFICE BOX 25179 St. Louis, MO 63125 |
| Contact | Karen E Tidd |
| Correspondent | Karen E Tidd SIMMLER, INC. POST OFFICE BOX 25179 St. Louis, MO 63125 |
| Product Code | CFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-22 |
| Decision Date | 1987-06-05 |