The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Glucose (hk) Reagent (procedure No.16).
| Device ID | K945908 |
| 510k Number | K945908 |
| Device Name: | GLUCOSE (HK) REAGENT (PROCEDURE NO.16) |
| Classification | Hexokinase, Glucose |
| Applicant | SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St. Louis, MO 63103 |
| Contact | Hoyle D Hill |
| Correspondent | Hoyle D Hill SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St. Louis, MO 63103 |
| Product Code | CFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-02 |
| Decision Date | 1995-05-08 |