DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270
FDA 510(k) clearance K073055 · decided 2008-01-03
Clearance details
- K-number
- K073055
- Device name
- DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270
- Applicant
- Dade Behring, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-10-30
- Decision date
- 2008-01-03
- Days to decision
- 65 days
- Clearance type
- Traditional
- Product code
- JFY
- Device class
- 2
- Regulation number
- 862.1225
- 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 |
|---|---|---|
| Dimension Enzymatic Creatinine, Siemens Material Number 10471520, UDI Number 0084276803051 recall (Z-2284-2020) | Siemens Healthcare Diagnostics, Inc. | 2020-06-05 |
| Dimension Enzymatic Creatinine (EZCR) reagent, SMN 10471520 recall (Z-1232-2020) | Siemens Healthcare Diagnostics, Inc. | 2020-01-24 |
| Siemens Dimension(R) EZCR Flex(R) Reagent Cartridge. Catalog number DF270B. In vitro diagn recall (Z-2177-2011) | Siemens Healthcare Diagnostics, Inc. | 2011-05-10 |
| Dimension Enzymatic Creatinine Flex reagent cartridge, DF270. The ECRE method is an in vit recall (Z-0485-2009) | Dade Behring, Inc. | 2008-12-13 |
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 |