The following data is part of a premarket notification filed by Sterling Biochemical, Inc. with the FDA for Glucose(hexokinase) Reagent Set.
| Device ID | K844998 |
| 510k Number | K844998 |
| Device Name: | GLUCOSE(HEXOKINASE) REAGENT SET |
| Classification | Hexokinase, Glucose |
| Applicant | STERLING BIOCHEMICAL, INC. 20200 W. OUTER DR. Dearborn, MI 48124 |
| Contact | David L Callender |
| Correspondent | David L Callender STERLING BIOCHEMICAL, INC. 20200 W. OUTER DR. Dearborn, MI 48124 |
| Product Code | CFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-26 |
| Decision Date | 1985-01-18 |