Secquire Cell Separator
FDA 510(k) K024080 · Perfusion Partners & Assoc., Inc.
510(k) numberK024080
Submission
- Device name
- Secquire Cell Separator
- Applicant
- Perfusion Partners & Assoc., Inc.
Crofton, MD, US - Received
- December 10, 2002
- Decision date
- July 2, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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| K042473 | Cobe Angel Whole Blood Separation SystemJQC · Abbreviated | Cobe Cardiovascular, Inc. | 11/19/2004SE |
| 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 |
| K021902 | Magellan Autologus Platelet Separator, MAG100, Magellan Autologous Platelet Separator…JQC · Traditional | Medtronic Vascular | 08/12/2002SE |
More from Medtronic Vascular
| 510(k) | Device | Decision |
|---|---|---|
| K070666 | Genesiscs Component Concentrating SystemJQC · Traditional | 06/20/2007SE |
Questions and answers
When was Secquire Cell Separator cleared by the FDA?
Secquire Cell Separator (K024080) received a 510(k) decision of Substantially Equivalent on July 2, 2003, 204 days after the submission was received.
What is the product code of K024080?
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.