PATHFAST NTPROBNP AND D-DIMER TESTS
FDA 510(k) clearance K072189 · decided 2008-02-05
Clearance details
- K-number
- K072189
- Device name
- PATHFAST NTPROBNP AND D-DIMER TESTS
- Applicant
- Mitsubishi Kagaku Iatron
- Decision
- Substantially Equivalent
- Date received
- 2007-08-06
- Decision date
- 2008-02-05
- Days to decision
- 183 days
- Clearance type
- Traditional
- Product code
- NBC
- Device class
- 2
- Regulation number
- 862.1117
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Seattle, WA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Mitsubishi Kagaku Iatron
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.