The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Dimension Ammonia Flex Reagent Cartridge.
| Device ID | K123320 |
| 510k Number | K123320 |
| Device Name: | DIMENSION AMMONIA FLEX REAGENT CARTRIDGE |
| Classification | Enzymatic Method, Ammonia |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS MS 514, PO BOX 6101 Newark, DE 19714 -6101 |
| Contact | Rose T Marinelli |
| Correspondent | Rose T Marinelli SIEMENS HEALTHCARE DIAGNOSTICS MS 514, PO BOX 6101 Newark, DE 19714 -6101 |
| Product Code | JIF |
| CFR Regulation Number | 862.1065 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-26 |
| Decision Date | 2013-02-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414948096 | K123320 | 000 |
| 00630414595832 | K123320 | 000 |