BCS SYSTEM
FDA 510(k) clearance K013114 · decided 2001-11-09
Clearance details
- K-number
- K013114
- Device name
- BCS SYSTEM
- Applicant
- Dade Behring, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-09-18
- Decision date
- 2001-11-09
- Days to decision
- 52 days
- Clearance type
- Traditional
- Product code
- JPA
- Device class
- 2
- Regulation number
- 864.5425
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Newark, DE, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BCS Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulat recall (Z-0824-2016) | Siemens Healthcare Diagnostics, Inc. | 2016-02-19 |
| BCS(R) Behring Coagulation System, Device catalog No. OVIO03 Product Usage: Multipurpose s recall (Z-1867-2012) | Siemens Healthcare Diagnostics, Inc. | 2012-06-26 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| COBAS INTEGRA 400 PLUS CYCLOSPORINE (P920031/S003) | Dade Behring, Inc. | 2002-07-24 |
| COBAS INTEGRA CYCLOSPORINE (P920031/S002) | Dade Behring, Inc. | 2002-02-26 |
| EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY (P920031/S001) | Dade Behring, Inc. | 2000-08-11 |
| EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY (P920031) | Dade Behring, Inc. | 1996-10-02 |