The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Iqm (intelligent Quality Management) On The Gem Premier 3000, Cvp (calibration Validation Product).
| Device ID | K022158 |
| 510k Number | K022158 |
| Device Name: | IQM (INTELLIGENT QUALITY MANAGEMENT) ON THE GEM PREMIER 3000, CVP (CALIBRATION VALIDATION PRODUCT) |
| 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 |
| Subsequent Product Code | GFS |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-02 |
| Decision Date | 2002-09-10 |
| Summary: | summary |