FDA 510(k)

PATHFAST CK-MB-II CALIBRATORS

K-Number: K130628 · 2013-10-04

ApplicantMitsubishi Chemical Medience Corporation

Decision Date2013-10-04

Product CodeJIT

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

PATHFAST CK-MB-II CALIBRATORS is the device name listed in this FDA 510(k) record. The listed applicant is Mitsubishi Chemical Medience Corporation. It received FDA 510(k) clearance on 2013-10-04 under 510(k) number K130628. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PATHFAST CK-MB-II CALIBRATORS?

PATHFAST CK-MB-II CALIBRATORS is a medical device that received FDA 510(k) clearance on 2013-10-04. The listed applicant is Mitsubishi Chemical Medience Corporation. The 510(k) number is K130628.

When did PATHFAST CK-MB-II CALIBRATORS receive FDA 510(k) clearance?

PATHFAST CK-MB-II CALIBRATORS received FDA 510(k) clearance on 2013-10-04, under 510(k) number K130628.

Who is the listed applicant for PATHFAST CK-MB-II CALIBRATORS?

The FDA 510(k) record lists Mitsubishi Chemical Medience Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PATHFAST CK-MB-II CALIBRATORS?

The FDA product code for PATHFAST CK-MB-II CALIBRATORS is JIT.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.