The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Dimension Tni Flex Reagent Cartridge, And Ctni Sample Diluent With Models, Rf621, Kd692.
| Device ID | K081643 |
| 510k Number | K081643 |
| Device Name: | DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692 |
| Classification | Immunoassay Method, Troponin Subunit |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS MS 514, PO BOX 6101 Newark, DE 19714 -6101 |
| Contact | Yuk-ting Lewis |
| Correspondent | Yuk-ting Lewis SIEMENS HEALTHCARE DIAGNOSTICS MS 514, PO BOX 6101 Newark, DE 19714 -6101 |
| Product Code | MMI |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-12 |
| Decision Date | 2008-07-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768022067 | K081643 | 000 |
| 00842768015892 | K081643 | 000 |