JQC · Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Clinical Chemistry · 21 CFR 862.2050 · Class 1
Overview
| Product Code | JQC |
|---|---|
| Device Name | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use |
| Regulation | 21 CFR 862.2050 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
| GMP Exempt | Yes |
Identification
General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.
Classification Rationale
Class I (general controls). The device is identified in paragraph (a) of this section and is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (20 of 38)
Showing 20 most recent of 38 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K183205 | PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System | Emcyte Corporation | May 30, 2019 | SESU |
| K103340 | SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM | Harvest Technologies, Corp. | Dec 6, 2010 | SESE |
| K081345 | AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY) | Thermogenesis Corp. | Jul 10, 2008 | SN |
| K071934 | MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT | Biomet Manufacturing Corp | Oct 11, 2007 | SESE |
| K070666 | GENESISCS COMPONENT CONCENTRATING SYSTEM | Perfusion Partners & Assoc., Inc. | Jun 20, 2007 | SESE |
| K052925 | SMARTPREP2 CENTRIFUGE SYSTEM | Harvest Technologies, Corp. | Jan 4, 2006 | SESE |
| K042473 | COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM | Cobe Cardiovascular, Inc. | Nov 19, 2004 | SESE |
| K024080 | SECQUIRE CELL SEPARATOR | Perfusion Partners & Assoc., Inc. | Jul 2, 2003 | SESE |
| K030555 | GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A | Biomet, Inc. | Apr 11, 2003 | SESE |
| K030340 | AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129) | Cytomedix | Apr 11, 2003 | SESE |
| K021902 | MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPARATOR DEISPOSABLE KIT, MKT300 | Medtronic Vascular | Aug 12, 2002 | SESE |
| K994148 | 3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM | Implant Innovations, Inc. | Feb 1, 2000 | SESE |
| K991430 | SMARTPREP CENTRIFUGE SYSTEM | Harvest Technologies, LLC | May 28, 1999 | SESE |
| K944738 | SERIES 600 CENTRIFUGE-FOUR SEPARATE VARIATIONS OF THE SAME BASE CENTRIFUGE | Ducker CL | Oct 19, 1994 | SESE |
| K881254 | STATSPIN DISPOSABLE ROTOR, PRODUCT #RD01 | Norfolk Scientific, Inc. | Apr 5, 1988 | SESE |
| K864974 | GENERAL PURPOSE CENTRIFUGE | Norfolk Scientific, Inc. | Jan 9, 1987 | SESE |
| K861146 | MODEL K110SX CENTRIFUGE | Jouan S.A. | May 5, 1986 | SESE |
| K860747 | DU PONT SORVALL CENTRIFUGES (RAPIDSPIN R) | E.I. Dupont DE Nemours & Co., Inc. | Apr 14, 1986 | SESE |
| K860172 | QWIKSPIN (TM) | Norfolk Scientific, Inc. | Feb 11, 1986 | SESE |
| K850485 | ROTOR SYSTEMS A/S-400 & LA/S-400 | E.I. Dupont DE Nemours & Co., Inc. | Mar 12, 1985 | SESE |
Top Applicants
- E.I. Dupont DE Nemours & Co., Inc. — 3 clearances
- Lkb Instruments, Inc. — 3 clearances
- Norfolk Scientific, Inc. — 3 clearances
- Biodynamics Corp. — 2 clearances
- Boehringer Mannheim Corp. — 2 clearances
