Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - DEN000010
Device Classification Name
Test,Natriuretic Peptide
More FDA Info for this Device
510(K) Number
DEN000010
Device Name
Test,Natriuretic Peptide
Applicant
BIOSITE INCORPORATED
11030 ROSELLE ST.
SAN DIEGO, CA 92121 US
Other 510(k) Applications for this Company
Contact
JEFF DAHLEN
Other 510(k) Applications for this Contact
Regulation Number
862.1117
More FDA Info for this Regulation Number
Classification Product Code
NBC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/15/2000
Decision Date
11/20/2000
Decision
DENG -
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Type
Post-NSE
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact