FDA Product Code
FDA Product Code JQC — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.2050
510(k) Clearances — 38 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K183205 | PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System | Emcyte Corporation | 2019-05-30 | Special | PDF ↗ |
| K103340 | SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM | Harvest Technologies, Corp. | 2010-12-06 | Special | PDF ↗ |
| K081345 | AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY) | Thermogenesis Corp. | 2008-07-10 | Abbreviated | PDF ↗ |
| K071934 | MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT | Biomet Manufacturing Corp | 2007-10-11 | Traditional | PDF ↗ |
| K070666 | GENESISCS COMPONENT CONCENTRATING SYSTEM | Perfusion Partners & Assoc., Inc. | 2007-06-20 | Traditional | PDF ↗ |
| K052925 | SMARTPREP2 CENTRIFUGE SYSTEM | Harvest Technologies, Corp. | 2006-01-04 | Traditional | PDF ↗ |
| K042473 | COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM | Cobe Cardiovascular, Inc. | 2004-11-19 | Abbreviated | PDF ↗ |
| K024080 | SECQUIRE CELL SEPARATOR | Perfusion Partners & Assoc., Inc. | 2003-07-02 | Traditional | PDF ↗ |
| K030340 | AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129) | Cytomedix | 2003-04-11 | Traditional | PDF ↗ |
| K030555 | GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A | Biomet, Inc. | 2003-04-11 | Traditional | PDF ↗ |
| K021902 | MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPARATOR DEISPOSABLE KIT, MKT300 | Medtronic Vascular | 2002-08-12 | Traditional | PDF ↗ |
| K994148 | 3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM | Implant Innovations, Inc. | 2000-02-01 | Traditional | PDF ↗ |
| K991430 | SMARTPREP CENTRIFUGE SYSTEM | Harvest Technologies, LLC | 1999-05-28 | Traditional | PDF ↗ |
| K944738 | SERIES 600 CENTRIFUGE-FOUR SEPARATE VARIATIONS OF THE SAME BASE CENTRIFUGE | Ducker CL | 1994-10-19 | Traditional | PDF ↗ |
| K881254 | STATSPIN DISPOSABLE ROTOR, PRODUCT #RD01 | Norfolk Scientific, Inc. | 1988-04-05 | Traditional | PDF ↗ |
| K864974 | GENERAL PURPOSE CENTRIFUGE | Norfolk Scientific, Inc. | 1987-01-09 | Traditional | PDF ↗ |
| K861146 | MODEL K110SX CENTRIFUGE | Jouan S.A. | 1986-05-05 | Traditional | PDF ↗ |
| K860747 | DU PONT SORVALL CENTRIFUGES (RAPIDSPIN R) | E.I. Dupont DE Nemours & Co., Inc. | 1986-04-14 | Traditional | PDF ↗ |
| K860172 | QWIKSPIN (TM) | Norfolk Scientific, Inc. | 1986-02-11 | Traditional | PDF ↗ |
| K850485 | ROTOR SYSTEMS A/S-400 & LA/S-400 | E.I. Dupont DE Nemours & Co., Inc. | 1985-03-12 | Traditional | PDF ↗ |
| K843434 | ISO-DATA CENTRIFUGES 1-A, 101, 2D, ETC. | Iso-Data, Inc. | 1984-10-05 | Traditional | PDF ↗ |
| K843087 | UNIVERSAL 2 S CENTRIFUGE | Boehringer Mannheim Corp. | 1984-08-29 | Traditional | PDF ↗ |
| K843088 | EBA 3 S CENTRIFUGE | Boehringer Mannheim Corp. | 1984-08-29 | Traditional | PDF ↗ |
| K840768 | CENTRIFUGES | Heraeus-Christ GmbH | 1984-05-07 | Traditional | PDF ↗ |
| K831947 | LKB 2160 MIDISPIN CENTRIFUGE | Lkb Instruments, Inc. | 1983-07-29 | Traditional | PDF ↗ |
| K831942 | LKB 2164 MACRO-SPIN R CENTRIFUGE | Lkb Instruments, Inc. | 1983-07-29 | Traditional | PDF ↗ |
| K831948 | LKB 2161 MIDISPIN R CENTRIFUGE | Lkb Instruments, Inc. | 1983-07-29 | Traditional | PDF ↗ |
| K822715 | PLATELET CENTRIFUGE | Biodynamics Corp. | 1982-09-30 | Traditional | PDF ↗ |
| K822422 | BASIC CENTRIFUGE | Biodynamics Corp. | 1982-09-02 | Traditional | PDF ↗ |
| K821756 | IEC CENTRA 4 CENTRIFUGE | International Equipment Co. | 1982-06-25 | Traditional | PDF ↗ |
| K813524 | CENTIDISC | Bel-Art Products | 1981-12-31 | Traditional | PDF ↗ |
| K812505 | PALL ULTIPOR VACUUM LINE BACTERIA FITLER | Pall Biomedical Products Co. | 1981-09-16 | Traditional | PDF ↗ |
| K810833 | SORVALL RT6000 REFRIGERATED TABLETOP | E.I. Dupont DE Nemours & Co., Inc. | 1981-04-08 | Traditional | PDF ↗ |
| K802210 | CONICAL TIPPED CENTRIFUGE TUBE 15M | Scientific Specialties, Inc. | 1980-09-26 | Traditional | PDF ↗ |
| K800381 | REFRIG. CENTRIFUGE (DRUCKER MODEL) | Coulter Electronics, Inc. | 1980-03-19 | Traditional | PDF ↗ |
| K782124 | IEC CENTRA-7 CENTRIFUGE MODEL 2362 | Damon Corp. | 1979-02-26 | Traditional | PDF ↗ |
| K761013 | SPINETTE CENTRIFUGE | Damon Corp. | 1976-11-16 | Traditional | PDF ↗ |
| K760467 | ROTATOR, FIXED SPEED | Lederle Laboratories | 1976-10-29 | Traditional | PDF ↗ |
Product code JQC · Class I · Clinical Chemistry. Data: openFDA.