GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)
FDA 510(k) K160415 · Instrumentation Laboratory CO
510(k) numberK160415
Submission
- Device name
- GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)
- Applicant
- Instrumentation Laboratory CO
Bedford, MA, US - Received
- February 12, 2016
- Decision date
- December 14, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GKF – Instrument, Hematocrit, Automated
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5600
- Specialty
- Hematology
Other 510(k)s with product code GKF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K983551 | Crit-Scan II MonitorGKF · Traditional | In-Line Diagnostics Corp. | 05/27/1999SE |
| K981427 | Stat Profile M AnalyzerGKF · Traditional | Nova Biomedical Corp. | 05/12/1998SE |
| K981426 | Stat Profile Ultra F,G,H,I,J,K, and L AnalyzersGKF · Traditional | Nova Biomedical Corp. | 05/12/1998SE |
| K981425 | Stat Profile Ultra a, B, C, D, and E AnalyzersGKF · Traditional | Nova Biomedical Corp. | 05/12/1998SE |
| K953519 | Microspin 24GKF · Traditional | Vulcon Technologies | 11/03/1995SE |
| K915825 | Marathon 6K General-Purpose CentrifugeGKF · Traditional | Fisher Scientific Co., LLC | 03/11/1992SE |
| K915441 | Marathon 13K/H Microhematocrit CentrifugeGKF · Traditional | Fisher Scientific Co., LLC | 01/08/1992SE |
| K904336 | New Cobe Saturation/Hematocrit MonitorGKF · Traditional | Cobe Laboratories, Inc. | 12/27/1990SE |
| K880373 | Ionometer E-Hk and AccessoriesGKF · Traditional | Smash Ent., Inc. | 03/17/1988SE |
| K870860 | Chempro 1000(TM)GKF · Traditional | Arden Medical Systems, Inc. | 04/14/1987SE |
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| K223608 | GEM Premier 7000 with IQM3CHL · Traditional | 08/10/2023SE |
| K223187 | HemosIL Liquid Anti-XaQLU · Traditional | 06/23/2023SE |
| K231031 | ACL TOP Family 70 SeriesGKP · Traditional | 06/21/2023SE |
| K223090 | GEM Premier ChemSTATCGA · Special | 01/27/2023SE |
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Questions and answers
When was GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation) cleared by the FDA?
GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation) (K160415) received a 510(k) decision of Substantially Equivalent on December 14, 2016, 306 days after the submission was received.
What is the product code of K160415?
The FDA product code is GKF – Instrument, Hematocrit, Automated, a Class II (moderate risk) device regulated under 21 CFR 864.5600.