510(k) K051596
K051596 is an FDA 510(k) premarket notification submitted by Nanogen, Inc. for the device "STATUSFIRST CHF (CONGESTIVE HEART FAILURE) NT-PROBNP, MODEL 20204". The FDA issued a decision of Substantially Equivalent on March 13, 2006. The device falls under product code NBC (Test, Natriuretic Peptide), a Class II device regulated under 21 CFR 862.1117. Nanogen, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 13, 2006
- Date Received
- June 16, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Natriuretic Peptide
- Device Class
- Class II
- Regulation Number
- 862.1117
- Review Panel
- CH
- Submission Type