K121907 is an FDA 510(k) clearance for the DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR. This device is classified as a Alpha-naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes (Class II - Special Controls, product code CJO).
Submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on July 23, 2012, 24 days after receiving the submission on June 29, 2012.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1050.
| 510(k) Number | K121907 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 29, 2012 |
| Decision Date | July 23, 2012 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CJO — Alpha-naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1050 |