The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Gem Premier 3000.
| Device ID | K052121 |
| 510k Number | K052121 |
| Device Name: | GEM PREMIER 3000 |
| Classification | Glucose Oxidase, Glucose |
| Applicant | INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford, MA 01730 |
| Contact | Carol Marble |
| Correspondent | Carol Marble INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford, MA 01730 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-05 |
| Decision Date | 2005-10-21 |
| Summary: | summary |