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FDA 510(k)

ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL

K-Number: K111005 · 2011-11-15

ApplicantMedica Corp.
Decision Date2011-11-15
Product CodeDIC
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Medica Corp.. It received FDA 510(k) clearance on 2011-11-15 under 510(k) number K111005. The device is classified under product code DIC. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL?

ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL is a medical device that received FDA 510(k) clearance on 2011-11-15. The listed applicant is Medica Corp.. The 510(k) number is K111005.

When did ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL receive FDA 510(k) clearance?

ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL received FDA 510(k) clearance on 2011-11-15, under 510(k) number K111005.

Who is the listed applicant for ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL?

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 ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL?

The FDA product code for ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL is DIC.

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Related Devices (Code: DIC)

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Official Source

View on FDA Database →

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

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