PATHFAST CK-MB-II, PATHFAST MYO-II— 510(k) K081360
Substantially EquivalentMitsubishi Kagaku Iatron
FDA 510(k) clearance K081360 for PATHFAST CK-MB-II, PATHFAST MYO-II, Substantially Equivalent on 2009-08-17. Applicant: Mitsubishi Kagaku Iatron. Device class: 2.
Clearance details
- Applicant
- Mitsubishi Kagaku Iatron
- Product code
- Code JHX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1215
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seattle, WA, US
Recent devices under product code JHX
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- K051650 — STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK.
More clearances from Mitsubishi Kagaku Iatron
view allRecalls naming K081360
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 K081360.
Data sourced from openFDA. This site is unofficial and independent of the FDA.