DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE
FDA 510(k) clearance K043546 · decided 2005-01-18
Clearance details
- K-number
- K043546
- Device name
- DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE
- Applicant
- Dade Behring, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-12-23
- Decision date
- 2005-01-18
- Days to decision
- 26 days
- Clearance type
- Special
- Product code
- CDT
- Device class
- 1
- Regulation number
- 862.1705
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Newark, DE, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Aptio Automation Storage and Retrieval Module (SRM) recall (Z-2091-2023) | Siemens Healthcare Diagnostics, Inc. | 2023-07-05 |
| Dimension Vista System StreamLAB Analytical Workcell. Dimension Vista System Part Numbers recall (Z-1205-2010) | Siemens Healthcare Diagnostics, Inc. | 2010-03-24 |
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 |