The following data is part of a premarket notification filed by Sterling Diagnostics, Inc. with the FDA for Glucose Reagent Set (god/trinder).
| Device ID | K854335 |
| 510k Number | K854335 |
| Device Name: | GLUCOSE REAGENT SET (GOD/TRINDER) |
| Classification | Glucose Oxidase, Glucose |
| Applicant | STERLING DIAGNOSTICS, INC. 34210 DEQUINDRE RD. Sterling Heights, MI 48077 |
| Contact | David L Callender |
| Correspondent | David L Callender STERLING DIAGNOSTICS, INC. 34210 DEQUINDRE RD. Sterling Heights, MI 48077 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-28 |
| Decision Date | 1985-11-22 |