The following data is part of a premarket notification filed by Amdev, Inc. with the FDA for Apec Glucose Analyzer.
| Device ID | K890524 |
| 510k Number | K890524 |
| Device Name: | APEC GLUCOSE ANALYZER |
| Classification | Glucose Oxidase, Glucose |
| Applicant | AMDEV, INC. 35 CHERRY HILL DR. Danvers, MA 01923 -2565 |
| Contact | Connie J Hertel |
| Correspondent | Connie J Hertel AMDEV, INC. 35 CHERRY HILL DR. Danvers, MA 01923 -2565 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-02 |
| Decision Date | 1989-03-15 |