510(k) K121907
- Device
- DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR
- Applicant
- SIEMENS HEALTHCARE DIAGNOSTICS
- 510(k) number
- K121907
- Product code
- CJO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-07-23
- Date received
- 2012-06-29
- Regulation
- 862.1050
- Classification name
- Alpha-naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROSE T MARINELLI
- Address
- P.O. Box 6101, Mailstap 514 Newark DE US 19714 19714
FDA Registration Numbers#
- 2517506
- 2432235
- 3004493545
Source Documents#
Other 510(k) Records For Product Code CJO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K122323 | DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI | Siemens Healthcare Diagnostics | 2012-08-28 |
| K982328 | BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) | Bayer Corp. | 1999-01-29 |
| K770155 | ALKALINE PHOSPHATASE ISOYZME REAGENT SET | Gelman Instrument Co. | 1977-01-31 |
Legacy Summary#
summary
FDA Review#
Decision Summary