The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Gem Premier 3000- Addition Of Glucose And Lactate As New Parameters.
| Device ID | K010520 |
| 510k Number | K010520 |
| Device Name: | GEM PREMIER 3000- ADDITION OF GLUCOSE AND LACTATE AS NEW PARAMETERS |
| Classification | Glucose Oxidase, Glucose |
| Applicant | INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford, MA 01730 |
| Contact | Reba Poirier |
| Correspondent | Reba Poirier INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford, MA 01730 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-22 |
| Decision Date | 2001-05-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950087915 | K010520 | 000 |
| 08426950087892 | K010520 | 000 |
| 08426950087878 | K010520 | 000 |
| 08426950087908 | K010520 | 000 |