The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Gem Premier 5000 (measured Parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation).
| Device ID | K160415 |
| 510k Number | K160415 |
| Device Name: | GEM Premier 5000 (Measured Parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation) |
| Classification | Instrument, Hematocrit, Automated |
| 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 | GKF |
| Subsequent Product Code | GHS |
| Subsequent Product Code | GKR |
| Subsequent Product Code | GLY |
| CFR Regulation Number | 864.5600 [🔎] |
| 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 |
|---|---|---|
| 08426950807537 | K160415 | 000 |
| 08426950807773 | K160415 | 000 |
| 08426950807711 | K160415 | 000 |
| 08426950807650 | K160415 | 000 |