Atlas FDA

PATHFAST CK-MB-II, PATHFAST MYO-II

FDA 510(k) clearance K081360 · decided 2009-08-17

Clearance details

K-number
K081360
Device name
PATHFAST CK-MB-II, PATHFAST MYO-II
Applicant
Mitsubishi Kagaku Iatron
Decision
Substantially Equivalent
Date received
2008-05-15
Decision date
2009-08-17
Days to decision
459 days
Clearance type
Traditional
Product code
JHX
Device class
2
Regulation number
862.1215
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Seattle, WA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.