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FDA 510(k)

IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT

K-Number: K050352 · 2005-09-01

ApplicantAmeritek Research, LLC
Decision Date2005-09-01
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Ameritek Research, LLC. It received FDA 510(k) clearance on 2005-09-01 under 510(k) number K050352. The device is classified under product code JTO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT?

IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT is a medical device that received FDA 510(k) clearance on 2005-09-01. The listed applicant is Ameritek Research, LLC. The 510(k) number is K050352.

When did IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT receive FDA 510(k) clearance?

IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT received FDA 510(k) clearance on 2005-09-01, under 510(k) number K050352.

Who is the listed applicant for IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT?

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

What is the FDA product code for IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT?

The FDA product code for IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT is JTO.

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Related Devices (Code: JTO)

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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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