ADVIA CHEMISTRY ENZYMATIC CREATININE_2
FDA 510(k) clearance K070727 · decided 2007-08-03
Clearance details
- K-number
- K070727
- Device name
- ADVIA CHEMISTRY ENZYMATIC CREATININE_2
- Applicant
- Siemens Medical Solutions Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2007-03-15
- Decision date
- 2007-08-03
- Days to decision
- 141 days
- Clearance type
- Traditional
- Product code
- JFY
- Device class
- 2
- Regulation number
- 862.1225
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Tarrytown, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ADVIA Chemistry Enzymatic Creatinine_2, Siemens Material Number 10335869, UDI Number 00630 recall (Z-2282-2020) | Siemens Healthcare Diagnostics, Inc. | 2020-06-05 |
| Atellica CH Enzymatic Creatinine_2, Siemens Material Number 11097533, UDI Number 006304145 recall (Z-2283-2020) | Siemens Healthcare Diagnostics, Inc. | 2020-06-05 |
| ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869 recall (Z-1230-2020) | Siemens Healthcare Diagnostics, Inc. | 2020-01-24 |
| Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533 recall (Z-1231-2020) | Siemens Healthcare Diagnostics, Inc. | 2020-01-24 |