The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Dimension Alkaline Phosphatase Flex Reagent Cartridge, Dimension Alkaline Phosphatase Calibrator.
| Device ID | K121907 |
| 510k Number | K121907 |
| Device Name: | DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR |
| Classification | Alpha-naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS P.O. BOX 6101, MAILSTAP 514 Newark, DE 19714 |
| Contact | Rose T Marinelli |
| Correspondent | Rose T Marinelli SIEMENS HEALTHCARE DIAGNOSTICS P.O. BOX 6101, MAILSTAP 514 Newark, DE 19714 |
| Product Code | CJO |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-29 |
| Decision Date | 2012-07-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414601199 | K121907 | 000 |
| 00630414600611 | K121907 | 000 |
| 00842768039027 | K121907 | 000 |
| 00842768039010 | K121907 | 000 |