510(k) K991430
- Device
- SMARTPREP CENTRIFUGE SYSTEM
- Applicant
- HARVEST TECHNOLOGIES, LLC.
- 510(k) number
- K991430
- Product code
- JQC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-05-28
- Date received
- 1999-04-26
- 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
- RICK LARIVIERE
- Address
- 77 Accord Park Dr. D-7 Norwell MA US 02061 02061
FDA Registration Numbers#
- 3021013124
- 1423537
- 3013576619
- 3010594904
- 3003402518
- 3027555954
- 1423662
- 3009407607
- 3015974593
- 3006897996
- 3028019212
- 3012821221
- 3043088937
- 3010394461
- 3019387954
- 9680602
- 3005778453
- 3015086789
- 3004198394
- 3016851379
- 3007123908
- 3011765035
- 8010471
- 3019269298
- 3029995182
- 3009302820
- 3010400367
- 3006788678
- 9617475
- 3014004349
- 3010455511
- 2032521
- 9616088
- 3010392991
- 3010331645
- 9617426
- 3016758972
- 9615162
- 9680411
- 3009963993
- 3014657561
- 3007448124
- 3011816315
- 3012481754
- 3031700059
- 3004417597
- 3027645317
- 3033273466
- 2025606
- 3003559191
- 3027339877
- 3015231789
- 9613959
- 3010402964
- 3005332796
- 3004111573
- 1061932
- 1825034
- 3017155466
- 3010408396
- 3017056269
- 8030607
- 2084346
- 3021639773
- 3010031137
- 1643817
- 3011230048
- 3015539532
- 3012942167
- 3011544811
- 3008773490
- 3021226419
- 1061124
- 3012187635
- 3019916040
- 3005273623
- 3043009938
- 1066491
- 3003965134
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 |
| K052925 | SMARTPREP2 CENTRIFUGE SYSTEM | Harvest Technologies, Corp. | 2006-01-04 |
| 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 |
| 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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