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FDA 510(k)

AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP)

K-Number: K113501 · 2011-12-05

ApplicantAmeditech, Inc.
Decision Date2011-12-05
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP) is the device name listed in this FDA 510(k) record. The listed applicant is Ameditech, Inc.. It received FDA 510(k) clearance on 2011-12-05 under 510(k) number K113501. The device is classified under product code DIO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP)?

AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP) is a medical device that received FDA 510(k) clearance on 2011-12-05. The listed applicant is Ameditech, Inc.. The 510(k) number is K113501.

When did AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP) receive FDA 510(k) clearance?

AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP) received FDA 510(k) clearance on 2011-12-05, under 510(k) number K113501.

Who is the listed applicant for AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP)?

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

What is the FDA product code for AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP)?

The FDA product code for AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP) is DIO.

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Other records listing Ameditech, Inc. as applicant

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Related Devices (Code: DIO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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