The following data is part of a premarket notification filed by Biosite Incorporated with the FDA for Triage Bnp Test For The Beckman Coulter Immunoassay Systems, Model Catalog #98200.
| Device ID | K033383 |
| 510k Number | K033383 |
| Device Name: | TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG #98200 |
| Classification | Test, Natriuretic Peptide |
| Applicant | BIOSITE INCORPORATED 11030 ROSELLE ST. San Diego, CA 92121 |
| Contact | Jeffrey R Dahlen, Ph.d. |
| Correspondent | Jeffrey R Dahlen, Ph.d. BIOSITE INCORPORATED 11030 ROSELLE ST. San Diego, CA 92121 |
| Product Code | NBC |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1117 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-23 |
| Decision Date | 2003-12-23 |
| Summary: | summary |