CREATININE METH FOR USE ON THE DIMENSION CLIN CHEM
FDA 510(k) clearance K925668 · decided 1992-12-28
Clearance details
- K-number
- K925668
- Device name
- CREATININE METH FOR USE ON THE DIMENSION CLIN CHEM
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-11-10
- Decision date
- 1992-12-28
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- CGX
- Device class
- 2
- Regulation number
- 862.1225
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Wilmington, DE, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Dimension CREA (Creatinine) and Dimension Vista CREA (Creatinine); The CREA method used on recall (Z-2741-2015) | Siemens Healthcare Diagnostics, Inc. | 2015-09-05 |
| Dimension(R) Creatinine Flex(R) Reagent Cartridges. The CREA method is an in vitro diagnos recall (Z-0772-2012) | Siemens Healthcare Diagnostics, Inc. | 2012-01-15 |