Panels › Clinical Chemistry › Product code JQC · Class 1
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Regulation 862.2050
0510(k)s in 12 months (38 all time)
2recalls in 12 months (18 all time)
3recalls that name a 510(k)
Top companies in JQC
| Company | 510(k)s | Recalls |
|---|---|---|
| Beckman Coulter Inc | 0 | 4 |
| E.I. Dupont DE Nemours & Co., Inc. | 3 | 0 |
| Harvest Technologies, Corp. | 3 | 0 |
| Lkb Instruments, Inc. | 3 | 0 |
| LW Scientific, Inc. | 0 | 3 |
| Norfolk Scientific, Inc. | 3 | 0 |
| Biodynamics Corp. | 2 | 0 |
| Biomet, Inc. | 1 | 1 |
| Boehringer Mannheim Corp. | 2 | 0 |
| Cygnus LLC | 0 | 2 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 21, 2026 | Beckman Coulter, Inc. ROTOR ASSY-SW41, Reference Number 331362, when the rotors are installed in the following centrifuges: Optima XPN-100 (Model Numbers A99846 and A94469), Optima XPN-90 (Model Numbers A99842 and A94468), Open, Classified |
JQC | None listed |
| Oct 21, 2026 | Beckman Coulter, Inc. ROTOR ASSY-SW40, Reference Number 331302, when the rotors are installed in the following centrifuges: Optima XPN-100 (Model Numbers A99846 and A94469), Optima XPN-90 (Model Numbers A99842 and A94468), Open, Classified |
JQC | None listed |
| Feb 6, 2019 | LW Scientific, Inc. LW Scientific ZIP IQ Combo Centrifuge, ZIC-CMBO-4RT3 Rev B
Product Usage:
used as a general purpose centrifuge to spin down blood in hematocrit tubes with additional rotors to spin other fluids in te Terminated |
JQC | None listed |
| Feb 6, 2019 | LW Scientific, Inc. LW Scientific ZIP IQ Combo Centrifuge, ZIC-CMBO-2RT3 Rev B
Product Usage:
used as a general purpose centrifuge to spin down blood in hematocrit tubes with additional rotor to spin other fluids in tes Terminated |
JQC | None listed |
| Feb 6, 2019 | LW Scientific, Inc. LW Scientific ZIP IQ PCV Centrifuge, ZIC-24HD-75T3 Rev C
Product Usage:
used as a general purpose centrifuge to spin down blood in hematocrit tubes Terminated |
JQC | None listed |
| Oct 20, 2017 | Terumo BCT, Inc. HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO Terminated |
JQC | K052925 K103340 +1 |
| Oct 20, 2017 | Terumo BCT, Inc. HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO Terminated |
JQC | K052925 K103340 +1 |
| Feb 5, 2016 | Beckman Coulter Inc. Allegra X-5 rotor yoke, Catalog No. (Instruments) B30589 and B30590 (Rotor) B30593. Product Labeling: IFU B29071AA.
Product Usage:
For In Vitro Diagnostic Use. The Allegra X-5 is intended for the sep Terminated |
JQC | None listed |
| Dec 23, 2014 | Iris Diagnostics RTH8 Rotor, P/N X01-005847-001. RTH8 used in the StatSpin Express 4 Horizontal Centrifuge, Model M510, Product No. SSH4.
The RTH8 rotor is used with the Statspin Express 4 Horizontal Centrifuge. Sta Terminated |
JQC | None listed |
| Jul 27, 2011 | Global Focus Marketing & Develop Global Focus Marketing and Distribution, Silencer S2200 Centrifuge Terminated |
JQC | None listed |
| May 10, 2011 | StatSpin, Inc., dba Iris Sample Processing Statspin Express 4 Centrifuge
Model Number: SSH4
Intended Use: Rapid Separation of plasma and serum from primary gel collection tubes Terminated |
JQC | None listed |
| Mar 11, 2010 | Becton Dickinson & Co. CLAY ADAMS Dynac III Centrifuge, 120V, Model Number 420104
DYNAC III is a multi-purpose centrifuge, designed for clinical laboratories performing separations in hematology, chemistry, urinalysis, blo Terminated |
JQC | None listed |
| Mar 4, 2010 | StatSpin, Inc., dba Iris Sample Processing StatSpin Express 4 Horizontal Centrifuge
Model # M510.
Intended Use: Rapid Separation of plasma and serum from primary gel collection tubes. Terminated |
JQC | None listed |
| Apr 17, 2009 | Biomet, Inc. Biomet Marrowstim Concentration Kit w/single Disposable Separator, Bone Marrow Needle, and 30 ml ACD-A. For use with BBI centrifuges only, sterile, Biomet Biologics, Warsaw, IN; REF 800-0611A and 800 Terminated |
JQC | K071934 |
| Nov 21, 2006 | Iris Sample Processing StatSpin Express 3 Centrifuge with RTX8 Rotor Model: M502 Terminated |
JQC | None listed |
| Feb 28, 2006 | Cygnus LLC Centrifuge Model CF-6 with lid lock. (Block Model Number OCT-VI). Units are distributed to Bloch Scientific, Holbrook, NY for Bloch''s customers MFT and Cascade. Terminated |
JQC | None listed |
| Feb 28, 2006 | Cygnus LLC Centrifuge Model CF-6 with lid lock. (Block Model number OCT-VI). Units are distributed to Bloch Scientific, Holbrook, NY for Bloch''s customers MFT and Cascade. Terminated |
JQC | None listed |
| Jul 20, 2004 | Beckman Coulter Inc Customized Automation Centrifuge, First and Second Generation. Terminated |
JQC | None listed |
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