510(k) K052925
- Device
- SMARTPREP2 CENTRIFUGE SYSTEM
- Applicant
- HARVEST TECHNOLOGIES, CORP.
- 510(k) number
- K052925
- Product code
- JQC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-01-04
- Date received
- 2005-10-18
- Regulation
- 862.2050
- Classification name
- Centrifuges (micro, Ultra, Refrigerated) For Clinical Use
- Medical specialty
- Clinical Chemistry
- Review panel
- Hematology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN D BONASERA
- Address
- 40 Grissom Rd. Plymouth MA US 02360 02360
FDA Registration Numbers#
- 3003755939
- 3015231789
- 3009711478
- 3007712511
- 3031700059
- 2050012
- 3017155466
- 3021336182
- 3008132398
- 3009963993
- 3008412416
- 1066491
- 3029995182
- 3021013124
- 1616487
- 3010408396
- 3021639773
- 9616088
- 3011966385
- 3004548776
- 3009746061
- 3033848228
- 1721676
- 3011765035
- 3017036472
- 9680602
- 3010386080
- 3006788678
- 3015505238
- 3004198394
- 3027645317
- 3043138885
- 3004417597
- 3015086789
- 3015651306
- 3007448124
- 3017056269
- 3014004349
- 3007123908
- 3003510542
- 3032542289
- 2084346
- 3008773490
- 3009423112
- 3012329552
- 3007895168
- 3012101664
- 1423662
- 1423537
- 3015539532
- 3030516433
- 2032098
- 3014326253
- 3010047203
- 3006404071
- 3003965134
- 3016919945
- 3020704423
- 3031184338
- 3027555954
- 9680411
- 3007193505
- 3004488394
- 1643817
- 3030178466
- 3012481754
- 3006897996
- 3019916040
- 3010420046
- 3042989733
- 3016758972
- 3015806723
- 3010402964
- 3013576619
- 3017450368
- 1066733
- 3019387954
- 9613959
- 1836161
Source Documents#
Other 510(k) Records For Product Code JQC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K103340 | SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM | Harvest Technologies, Corp. | 2010-12-06 |
| K081345 | AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY) | Thermogenesis Corp. | 2008-07-10 |
| K071934 | MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT | Biomet Manufacturing Corp | 2007-10-11 |
| K070666 | GENESISCS COMPONENT CONCENTRATING SYSTEM | Perfusion Partners & Assoc., Inc. | 2007-06-20 |
| K042473 | COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM | Cobe Cardiovascular, Inc. | 2004-11-19 |
| K024080 | SECQUIRE CELL SEPARATOR | Perfusion Partners & Assoc., Inc. | 2003-07-02 |
| K030340 | AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129) | Cytomedix | 2003-04-11 |
| K030555 | GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A | Biomet, Inc. | 2003-04-11 |
| K021902 | MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPARATOR DEISPOSABLE KIT, MKT300 | Medtronic Vascular | 2002-08-12 |
| K994148 | 3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM | Implant Innovations, Inc. | 2000-02-01 |
| K991430 | SMARTPREP CENTRIFUGE SYSTEM | Harvest Technologies, LLC | 1999-05-28 |
| K944738 | SERIES 600 CENTRIFUGE-FOUR SEPARATE VARIATIONS OF THE SAME BASE CENTRIFUGE | Ducker CL | 1994-10-19 |
| K881254 | STATSPIN DISPOSABLE ROTOR, PRODUCT #RD01 | Norfolk Scientific, Inc. | 1988-04-05 |
| K864974 | GENERAL PURPOSE CENTRIFUGE | Norfolk Scientific, Inc. | 1987-01-09 |
Legacy Summary#
summary
FDA Review#
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