DIMENSION HAIC ASSAY, MODEL DF105
FDA 510(k) clearance K011852 · decided 2001-11-15
Clearance details
- K-number
- K011852
- Device name
- DIMENSION HAIC ASSAY, MODEL DF105
- Applicant
- Dade Behring, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-06-12
- Decision date
- 2001-11-15
- Days to decision
- 156 days
- Clearance type
- Traditional
- Product code
- LCP
- Device class
- 2
- Regulation number
- 864.7470
- 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 |
|---|---|---|
| HB1C Flex(R) Reagent Cartridge (DF105A, Siemens Material Number 10483822) for the Dimensio recall (Z-0625-2014) | Siemens Healthcare Diagnostics, Inc. | 2014-01-03 |
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 |