510(k) K072189
K072189 is an FDA 510(k) premarket notification submitted by Mitsubishi Kagaku Iatron for the device "PATHFAST NTPROBNP AND D-DIMER TESTS". The FDA issued a decision of Substantially Equivalent on February 5, 2008. The device falls under product code NBC (Test, Natriuretic Peptide), a Class II device regulated under 21 CFR 862.1117. Mitsubishi Kagaku Iatron has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 5, 2008
- Date Received
- August 6, 2007
- 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