The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Dimension Vista N-terminal Pro-brain Natriuretic Peptide (pbnp) Flex Reagent Cartridge (k6423a), Dimension Vista.
| Device ID | K080578 |
| 510k Number | K080578 |
| Device Name: | DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT CARTRIDGE (K6423A), DIMENSION VISTA |
| Classification | Test, Natriuretic Peptide |
| Applicant | Siemens Healthcare Diagnostics Inc. PO BOX 6101 MAILBOX 514 Newark, DE 19714 -6101 |
| Contact | Victor M Carrio |
| Correspondent | Victor M Carrio Siemens Healthcare Diagnostics Inc. PO BOX 6101 MAILBOX 514 Newark, DE 19714 -6101 |
| Product Code | NBC |
| CFR Regulation Number | 862.1117 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-03 |
| Decision Date | 2008-05-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768025129 | K080578 | 000 |
| 00842768025112 | K080578 | 000 |