Platelet Centrifuge
FDA 510(k) K822715 · Biodynamics Corp.
510(k) numberK822715
Submission
- Device name
- Platelet Centrifuge
- Applicant
- Biodynamics Corp.
Mchenry, IL, US - Received
- September 7, 1982
- Decision date
- September 30, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JQC – Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2050
- Specialty
- Clinical Chemistry
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| K183205 | PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic…JQC · Special | Emcyte Corporation | 05/30/2019SESU |
| K103340 | SMARTPREP2 Bmac System, Smartprep Platelet Concentration SystemJQC · Special | Harvest Technologies, Corp. | 12/06/2010SE |
| K081345 | Axp Platform Marrow Xpress System Model 8-5137, 8-5138, 8-5139, 8-5140 (Primary)JQC · Abbreviated | Thermogenesis Corp. | 07/10/2008SN |
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| K052925 | SMARTPREP2 Centrifuge SystemJQC · Traditional | Harvest Technologies, Corp. | 01/04/2006SE |
| K042473 | Cobe Angel Whole Blood Separation SystemJQC · Abbreviated | Cobe Cardiovascular, Inc. | 11/19/2004SE |
| K024080 | Secquire Cell SeparatorJQC · Traditional | Perfusion Partners & Assoc., Inc. | 07/02/2003SE |
| K030555 | GPS Platelet Separation Kit with Anticoagulant Acd-AJQC · Traditional | Biomet, Inc. | 04/11/2003SE |
| K030340 | Autologel Process Centrifuge, Model B4360 (100-103, 100-129)JQC · Traditional | Cytomedix | 04/11/2003SE |
More from Cytomedix
| 510(k) | Device | Decision |
|---|---|---|
| K051675 | Biodynamics Bia 500 Biompedance Body Composition AnalyzerMNW · Traditional | 03/16/2006SE |
| K884033 | Biodynamics Model 200 Body Composition AnalyzerDSB · Traditional | 11/17/1988SE |
| K881631 | Biodynamics Autotransfusion ReservoirCAC · Traditional | 09/09/1988SE |
| K881968 | Biodynamics Model BI-400 Body Composition AnalyzerDSB · Traditional | 07/28/1988SE |
| K874361 | Biodynamics Model BI-300 Body Composition AnalyzerDSB · Traditional | 03/16/1988SE |
| K873807 | Autotransfusion ApparatusCAC · Traditional | 03/09/1988SE |
| K874034 | ADR-22 Automatic Dialyzer ReprocessorLIF · Traditional | 10/23/1987SE |
| K870052 | Infumix Mixing ContainerKPE · Traditional | 02/27/1987SE |
| K822716 | Universal CentrifugeJPI · Traditional | 09/30/1982SE |
| K822422 | Basic CentrifugeJQC · Traditional | 09/02/1982SE |
Questions and answers
When was Platelet Centrifuge cleared by the FDA?
Platelet Centrifuge (K822715) received a 510(k) decision of Substantially Equivalent on September 30, 1982, 23 days after the submission was received.
What is the product code of K822715?
The FDA product code is JQC – Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2050.