The following data is part of a premarket notification filed by Biosite Incorporated with the FDA for Triage B-type Natriuretic Peptide (bnp) Test, Catalog #98000.
Device ID | K010266 |
510k Number | K010266 |
Device Name: | TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000 |
Classification | Test, Natriuretic Peptide |
Applicant | BIOSITE INCORPORATED 11030 ROSELLE ST. San Diego, CA 92121 |
Contact | Jeffrey R Dahlen |
Correspondent | Jeffrey R Dahlen BIOSITE INCORPORATED 11030 ROSELLE ST. 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 | 2001-01-29 |
Decision Date | 2001-03-16 |