DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR
FDA 510(k) clearance K121907 · decided 2012-07-23
Clearance details
- K-number
- K121907
- Device name
- DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR
- Applicant
- Siemens Healthcare Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2012-06-29
- Decision date
- 2012-07-23
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- CJO
- Device class
- 2
- Regulation number
- 862.1050
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Newark, DE, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI (K122323) | Siemens Healthcare Diagnostics | 2012-08-28 |
| BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) (K982328) | Bayer Corp. | 1999-01-29 |
| ALKALINE PHOSPHATASE ISOYZME REAGENT SET (K770155) | Gelman Instrument Co. | 1977-01-31 |
Recalls involving this device
No recalls on record reference this clearance.
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