PATHFAST HSCRP— 510(k) K083412

Substantially Equivalent

Mitsubishi Kagaku Iatron

FDA 510(k) clearance K083412 for PATHFAST HSCRP, Substantially Equivalent on 2009-03-09. Applicant: Mitsubishi Kagaku Iatron. Device class: 2.

Clearance details

Applicant: Mitsubishi Kagaku Iatron
Product code: Code DCN
Device class: Class 2
Regulation: 21 CFR 866.5270
Advisory panel: Immunology
Date received: 2008-11-18
Decision date: 2009-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Mitsubishi Kagaku Iatron

K081360 — PATHFAST CK-MB-II, PATHFAST MYO-II2009-08-17
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K072189 — PATHFAST NTPROBNP AND D-DIMER TESTS2008-02-05

Data sourced from openFDA. This site is unofficial and independent of the FDA.