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FDA 510(k)

GENZYME OSOM TRICHOMONAS RAPID TEST

K-Number: K033864 · 2004-04-02

ApplicantGenzyme Corp.
Decision Date2004-04-02
Product CodeJWZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GENZYME OSOM TRICHOMONAS RAPID TEST is the device name listed in this FDA 510(k) record. The listed applicant is Genzyme Corp.. It received FDA 510(k) clearance on 2004-04-02 under 510(k) number K033864. 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 GENZYME OSOM TRICHOMONAS RAPID TEST?

GENZYME OSOM TRICHOMONAS RAPID TEST is a medical device that received FDA 510(k) clearance on 2004-04-02. The listed applicant is Genzyme Corp.. The 510(k) number is K033864.

When did GENZYME OSOM TRICHOMONAS RAPID TEST receive FDA 510(k) clearance?

GENZYME OSOM TRICHOMONAS RAPID TEST received FDA 510(k) clearance on 2004-04-02, under 510(k) number K033864.

Who is the listed applicant for GENZYME OSOM TRICHOMONAS RAPID TEST?

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

What is the FDA product code for GENZYME OSOM TRICHOMONAS RAPID TEST?

The FDA product code for GENZYME OSOM TRICHOMONAS RAPID TEST is JWZ.

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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.

K020595XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01Xenotope Diagnostics, Inc.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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