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FDA 510(k)

EASYRA GLU-H REAGENT, MODEL 10200

K-Number: K092506 · 2009-09-16

ApplicantMedica Corp.
Decision Date2009-09-16
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EASYRA GLU-H REAGENT, MODEL 10200 is the device name listed in this FDA 510(k) record. The listed applicant is Medica Corp.. It received FDA 510(k) clearance on 2009-09-16 under 510(k) number K092506. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EASYRA GLU-H REAGENT, MODEL 10200?

EASYRA GLU-H REAGENT, MODEL 10200 is a medical device that received FDA 510(k) clearance on 2009-09-16. The listed applicant is Medica Corp.. The 510(k) number is K092506.

When did EASYRA GLU-H REAGENT, MODEL 10200 receive FDA 510(k) clearance?

EASYRA GLU-H REAGENT, MODEL 10200 received FDA 510(k) clearance on 2009-09-16, under 510(k) number K092506.

Who is the listed applicant for EASYRA GLU-H REAGENT, MODEL 10200?

The FDA 510(k) record lists Medica Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EASYRA GLU-H REAGENT, MODEL 10200?

The FDA product code for EASYRA GLU-H REAGENT, MODEL 10200 is CFR.

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Related Devices (Code: CFR)

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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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