ETOH FLEX REAGENT CARTRIDGE (DF22)
FDA 510(k) clearance K071811 · decided 2007-08-24
Clearance details
- K-number
- K071811
- Device name
- ETOH FLEX REAGENT CARTRIDGE (DF22)
- Applicant
- Dade Behring, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-07-03
- Decision date
- 2007-08-24
- Days to decision
- 52 days
- Clearance type
- Traditional
- Product code
- DIC
- Device class
- 2
- Regulation number
- 862.3040
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Newark, DE, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 006 recall (Z-1599-2020) | Siemens Healthcare Diagnostics, Inc. | 2020-02-27 |
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 |