The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista Pbnp Flex Reagent Cartridge And Calibrator.
| Device ID | K061795 |
| 510k Number | K061795 |
| Device Name: | DIMENSION VISTA PBNP FLEX REAGENT CARTRIDGE AND CALIBRATOR |
| Classification | Test, Natriuretic Peptide |
| Applicant | DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 MAIL BOX 514 P.o. Box 6101, Newark, DE 19714 -6101 |
| Contact | Pamela A Junga |
| Correspondent | Pamela A Junga DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 MAIL BOX 514 P.o. Box 6101, 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 | 2006-06-23 |
| Decision Date | 2006-09-11 |
| Summary: | summary |