PATHFAST D-DIMER— 510(k) K072288
Substantially EquivalentMitsubishi Kagaku Iatron
FDA 510(k) clearance K072288 for PATHFAST D-DIMER, Substantially Equivalent on 2009-05-06. Applicant: Mitsubishi Kagaku Iatron. Device class: 2.
Clearance details
- Applicant
- Mitsubishi Kagaku Iatron
- Product code
- Code GHH
- Device class
- Class 2
- Regulation
- 21 CFR 864.7320
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seattle, WA, US
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- K030740 — MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM
More clearances from Mitsubishi Kagaku Iatron
view allRecalls naming K072288
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 K072288.
Data sourced from openFDA. This site is unofficial and independent of the FDA.