PF4 ENHANCED SOLID PHASE ELISA
FDA 510(k) clearance K053559 · decided 2006-01-20
Clearance details
- K-number
- K053559
- Device name
- PF4 ENHANCED SOLID PHASE ELISA
- Applicant
- Genetic Testing Institute
- Decision
- Substantially Equivalent
- Date received
- 2005-12-21
- Decision date
- 2006-01-20
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- LCO
- Device class
- 2
- Regulation number
- 864.7695
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Waukesha, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| PF4 Concentrated Wash (10x), REF 403624, packaged in the following assay kits: 1. ImmucorG recall (Z-1001-2015) | Genetic Testing Institute,inc | 2015-01-20 |
| Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is designed a recall (Z-1022-2013) | Genetic Testing Institute,inc | 2013-03-28 |