The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Gem Premier 3000.
| Device ID | K161818 |
| 510k Number | K161818 |
| Device Name: | GEM Premier 3000 |
| Classification | Glucose Oxidase, Glucose |
| Applicant | Instrumentation Laboratory Co. 180 Hartwell Road Bedford, MA 01730 |
| Contact | Nikita Malladi |
| Correspondent | Nikita Malladi Instrumentation Laboratory Co. 180 Hartwell Road Bedford, MA 01730 |
| Product Code | CGA |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CHL |
| Subsequent Product Code | JFP |
| Subsequent Product Code | JGS |
| Subsequent Product Code | KFG |
| Subsequent Product Code | KHP |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-01 |
| Decision Date | 2016-09-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950452553 | K161818 | 000 |