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FDA 510(k)

XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01

K-Number: K020595 · 2003-02-20

ApplicantXenotope Diagnostics, Inc.
Decision Date2003-02-20
Product CodeJWZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01 is the device name listed in this FDA 510(k) record. The listed applicant is Xenotope Diagnostics, Inc.. It received FDA 510(k) clearance on 2003-02-20 under 510(k) number K020595. The device is classified under product code JWZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01?

XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01 is a medical device that received FDA 510(k) clearance on 2003-02-20. The listed applicant is Xenotope Diagnostics, Inc.. The 510(k) number is K020595.

When did XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01 receive FDA 510(k) clearance?

XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01 received FDA 510(k) clearance on 2003-02-20, under 510(k) number K020595.

Who is the listed applicant for XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01?

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

What is the FDA product code for XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01?

The FDA product code for XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01 is JWZ.

Related Clinical Trials

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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Related Devices (Code: JWZ)

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.

K033864GENZYME OSOM TRICHOMONAS RAPID TESTGenzyme Corp.K020226XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT; CATALOG NUMBERS S1383.01, S1383.02 & S1383.03Hellen Professional ServicesK894246MERIVIEW TM TRICHOMONASMeridian Diagnostics, Inc.K892802SUPER DUOMercia Diagnostics , Ltd.K892263MERIFLUOR(TM) -TRICHOMONASMeridian Diagnostics, Inc.K875138TRICHOMATE(R) SUPERMercia Diagnostics , Ltd.

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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