Marathon 6K General-Purpose Centrifuge
FDA 510(k) K915825 · Fisher Scientific Co., LLC
510(k) numberK915825
Submission
- Device name
- Marathon 6K General-Purpose Centrifuge
- Applicant
- Fisher Scientific Co., LLC
Indiana, PA, US - Received
- December 30, 1991
- Decision date
- March 11, 1992
- 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 |
|---|---|---|---|
| K160415 | GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin…GKF · Traditional | Instrumentation Laboratory CO | 12/14/2016SE |
| 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 |
| 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 |
More from Arden Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K930415 | Microhematocrit RotorGKG · Traditional | 03/23/1993SE |
| K915441 | Marathon 13K/H Microhematocrit CentrifugeGKF · Traditional | 01/08/1992SE |
| K890534 | Modified Uriqual(Tm) Urinalysis Control Level 1JJW · Traditional | 03/08/1989SE |
| K881275 | Uriqual(Tm) Urinalysis Controls (Human) I & IIJJY · Traditional | 05/16/1988SE |
| K874054 | Fisher Diagnostics Hematall III Las ReagentGGK · Traditional | 10/20/1987SE |
| K872916 | Histomatic Slide Stainer, Code-On VersionKPA · Traditional | 09/14/1987SE |
| K871058 | Serachem Liquid Spinal Fluid Control (Human)JJY · Traditional | 04/06/1987SE |
| K863224 | Hematall-C Plus Hematology ControlsJPK · Traditional | 10/29/1986SE |
| K862318 | Fisher Diagnostics Hematall-C CalibratorJPK · Traditional | 07/10/1986SE |
| K861185 | Therachem-Plus, Tri-Level TDC (TM)JJY · Traditional | 05/23/1986SE |
Questions and answers
When was Marathon 6K General-Purpose Centrifuge cleared by the FDA?
Marathon 6K General-Purpose Centrifuge (K915825) received a 510(k) decision of Substantially Equivalent on March 11, 1992, 72 days after the submission was received.
What is the product code of K915825?
The FDA product code is GKF – Instrument, Hematocrit, Automated, a Class II (moderate risk) device regulated under 21 CFR 864.5600.