The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Gambro Analyz Mon Glucose/am-g & Disp Am-g Tub Set.
| Device ID | K860682 |
| 510k Number | K860682 |
| Device Name: | GAMBRO ANALYZ MON GLUCOSE/AM-G & DISP AM-G TUB SET |
| Classification | Glucose Oxidase, Glucose |
| Applicant | GAMBRO, INC. 600 KNIGHTSBRIDGE PKWY. Lincolnshire, IL 60069 |
| Contact | Jeffrey R Shideman |
| Correspondent | Jeffrey R Shideman GAMBRO, INC. 600 KNIGHTSBRIDGE PKWY. Lincolnshire, IL 60069 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-25 |
| Decision Date | 1986-08-29 |