The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Gem Premier 5000 (measured Parameters:glucose, Lactate And Total Bilirubin).
| Device ID | K160402 |
| 510k Number | K160402 |
| Device Name: | GEM Premier 5000 (Measured Parameters:Glucose, Lactate And Total Bilirubin) |
| Classification | Glucose Oxidase, Glucose |
| Applicant | Instrumentation Laboratory Co. 180 Hartwell Road Bedford, MA 01730 |
| Contact | Carol Murble |
| Correspondent | Carol Marble Instrumentation Laboratory Co. 180 Hartwell Road Bedford, MA 01730 |
| Product Code | CGA |
| Subsequent Product Code | KHP |
| Subsequent Product Code | MQM |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-12 |
| Decision Date | 2016-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950807667 | K160402 | 000 |
| 08426950807568 | K160402 | 000 |