SERIES 600 CENTRIFUGE-FOUR SEPARATE VARIATIONS OF THE SAME BASE CENTRIFUGE
FDA 510(k) clearance K944738 · decided 1994-10-19
Clearance details
- K-number
- K944738
- Device name
- SERIES 600 CENTRIFUGE-FOUR SEPARATE VARIATIONS OF THE SAME BASE CENTRIFUGE
- Applicant
- Ducker CL
- Decision
- Substantially Equivalent
- Date received
- 1994-09-26
- Decision date
- 1994-10-19
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- JQC
- Device class
- 1
- Regulation number
- 862.2050
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Sunrise, FL, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
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| GENESISCS COMPONENT CONCENTRATING SYSTEM (K070666) | Perfusion Partners & Assoc., Inc. | 2007-06-20 |
| SMARTPREP2 CENTRIFUGE SYSTEM (K052925) | Harvest Technologies, Corp. | 2006-01-04 |
| COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM (K042473) | Cobe Cardiovascular, Inc. | 2004-11-19 |
| SECQUIRE CELL SEPARATOR (K024080) | Perfusion Partners & Assoc., Inc. | 2003-07-02 |
| GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A (K030555) | Biomet, Inc. | 2003-04-11 |
| AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129) (K030340) | Cytomedix | 2003-04-11 |
| MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPARATOR DEISPOSABLE KIT, MKT300 (K021902) | Medtronic Vascular | 2002-08-12 |
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Recalls involving this device
No recalls on record reference this clearance.