The following data is part of a premarket notification filed by Biosite Incorporated with the FDA for Triage Bnp Test For Beckman Coulter Immunoassay Systems, Model 98200.
| Device ID | K052789 |
| 510k Number | K052789 |
| Device Name: | TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200 |
| Classification | Test, Natriuretic Peptide |
| Applicant | BIOSITE INCORPORATED 9975 Summers Ridge Road San Diego, CA 92121 |
| Contact | Rachael S Williamson |
| Correspondent | Rachael S Williamson BIOSITE INCORPORATED 9975 Summers Ridge Road San Diego, CA 92121 |
| Product Code | NBC |
| CFR Regulation Number | 862.1117 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-03 |
| Decision Date | 2006-01-23 |
| Summary: | summary |