PATHFAST NTPROBNP AND D-DIMER TESTS— 510(k) K072189
Substantially EquivalentMitsubishi Kagaku Iatron
FDA 510(k) clearance K072189 for PATHFAST NTPROBNP AND D-DIMER TESTS, Substantially Equivalent on 2008-02-05. Applicant: Mitsubishi Kagaku Iatron. Device class: 2.
Clearance details
- Applicant
- Mitsubishi Kagaku Iatron
- Product code
- Code NBC
- Device class
- Class 2
- Regulation
- 21 CFR 862.1117
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seattle, WA, US
Recent devices under product code NBC
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view allRecalls naming K072189
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K072189.
Data sourced from openFDA. This site is unofficial and independent of the FDA.