GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)
FDA 510(k) clearance K160415 · decided 2016-12-14
Clearance details
- K-number
- K160415
- Device name
- GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)
- Applicant
- Instrumentation Laboratory CO
- Decision
- Substantially Equivalent
- Date received
- 2016-02-12
- Decision date
- 2016-12-14
- Days to decision
- 306 days
- Clearance type
- Traditional
- Product code
- GKF
- Device class
- 2
- Regulation number
- 864.5600
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Bedford, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CRIT-SCAN II MONITOR (K983551) | In-Line Diagnostics Corp. | 1999-05-27 |
| STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS (K981426) | Nova Biomedical Corp. | 1998-05-12 |
| STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS (K981425) | Nova Biomedical Corp. | 1998-05-12 |
| STAT PROFILE M ANALYZER (K981427) | Nova Biomedical Corp. | 1998-05-12 |
| MICROSPIN 24 (K953519) | Vulcon Technologies | 1995-11-03 |
| MARATHON 6K GENERAL-PURPOSE CENTRIFUGE (K915825) | Fisher Scientific Co., LLC | 1992-03-11 |
| MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE (K915441) | Fisher Scientific Co., LLC | 1992-01-08 |
| NEW COBE SATURATION/HEMATOCRIT MONITOR (K904336) | Cobe Laboratories, Inc. | 1990-12-27 |
| IONOMETER E-HK AND ACCESSORIES (K880373) | Smash Ent., Inc. | 1988-03-17 |
| CHEMPRO 1000(TM) (K870860) | Arden Medical Systems, Inc. | 1987-04-14 |
| SORVALL CAPSPIN MICROHEMATOCRIT CENTRIFUGE (K864646) | E.I. Dupont DE Nemours & Co., Inc. | 1987-01-05 |
| MICROHEMATOCRIT CENTRIFUGE (K864039) | Plaza Medical, Inc. | 1986-10-29 |
Recalls involving this device
No recalls on record reference this clearance.