The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Dimension Exl N-ternmial Pro-brain Natriuretic Peptide (ntp) Flex Reagent Cartridge, Model Rf623.
| Device ID | K082645 |
| 510k Number | K082645 |
| Device Name: | DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT CARTRIDGE, MODEL RF623 |
| Classification | Test, Natriuretic Peptide |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS MS 514, PO BOX 6101 Newark, DE 19714 -6101 |
| Contact | Victor M Carrio |
| Correspondent | Victor M Carrio SIEMENS HEALTHCARE DIAGNOSTICS MS 514, PO BOX 6101 Newark, DE 19714 -6101 |
| Product Code | NBC |
| CFR Regulation Number | 862.1117 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-11 |
| Decision Date | 2008-09-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768029929 | K082645 | 000 |
| 00842768029912 | K082645 | 000 |