The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Gem Premier 5000 (measured Parameters:sodium, Potassium, Chloride, Ionized Calcium), Gem Cvp 5 Tbili, Gem System Evaluator, Gem Hematocrit Evaluator.
| Device ID | K160225 |
| 510k Number | K160225 |
| Device Name: | GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 TBili, GEM System Evaluator, GEM Hematocrit Evaluator |
| Classification | Electrode, Ion Specific, Sodium |
| 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 | JGS |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | GLK |
| Subsequent Product Code | JFP |
| Subsequent Product Code | JJE |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-29 |
| Decision Date | 2016-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950807827 | K160225 | 000 |
| 08426950807674 | K160225 | 000 |
| 08426950807643 | K160225 | 000 |
| 08426950807636 | K160225 | 000 |
| 08426950807629 | K160225 | 000 |
| 08426950807612 | K160225 | 000 |
| 08426950807605 | K160225 | 000 |
| 08426950807599 | K160225 | 000 |
| 08426950807582 | K160225 | 000 |
| 08426950807681 | K160225 | 000 |
| 08426950807698 | K160225 | 000 |
| 08426950807810 | K160225 | 000 |
| 08426950807803 | K160225 | 000 |
| 08426950807797 | K160225 | 000 |
| 08426950807766 | K160225 | 000 |
| 08426950807759 | K160225 | 000 |
| 08426950807742 | K160225 | 000 |
| 08426950807735 | K160225 | 000 |
| 08426950807704 | K160225 | 000 |
| 08426950807575 | K160225 | 000 |