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FDA 510(k)

PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2

K-Number: K100130 · 2011-05-16

ApplicantMitsubishi Chemical Medience CO
Decision Date2011-05-16
Product CodeMMI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2 is the device name listed in this FDA 510(k) record. The listed applicant is Mitsubishi Chemical Medience CO. It received FDA 510(k) clearance on 2011-05-16 under 510(k) number K100130. The device is classified under product code MMI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2?

PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2 is a medical device that received FDA 510(k) clearance on 2011-05-16. The listed applicant is Mitsubishi Chemical Medience CO. The 510(k) number is K100130.

When did PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2 receive FDA 510(k) clearance?

PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2 received FDA 510(k) clearance on 2011-05-16, under 510(k) number K100130.

Who is the listed applicant for PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2?

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

What is the FDA product code for PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2?

The FDA product code for PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2 is MMI.

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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.

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