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FDA 510(k)

TRICHOMONAS DIRECT ENZYME IMMUNOASSAY

K-Number: K874259 · 1987-12-07

ApplicantCalifornia Integrated Diagnostics, Inc.
Decision Date1987-12-07
Product CodeJWZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TRICHOMONAS DIRECT ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is California Integrated Diagnostics, Inc.. It received FDA 510(k) clearance on 1987-12-07 under 510(k) number K874259. 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 TRICHOMONAS DIRECT ENZYME IMMUNOASSAY?

TRICHOMONAS DIRECT ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1987-12-07. The listed applicant is California Integrated Diagnostics, Inc.. The 510(k) number is K874259.

When did TRICHOMONAS DIRECT ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

TRICHOMONAS DIRECT ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1987-12-07, under 510(k) number K874259.

Who is the listed applicant for TRICHOMONAS DIRECT ENZYME IMMUNOASSAY?

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

What is the FDA product code for TRICHOMONAS DIRECT ENZYME IMMUNOASSAY?

The FDA product code for TRICHOMONAS DIRECT ENZYME IMMUNOASSAY is JWZ.

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Other records listing California Integrated Diagnostics, Inc. as applicant

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.

K904095HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPINGK871278MODIFIED CHLAMYDIA DIRECT SPECIMEN TEST KITK871279MODIFIED TRICHOMONAS DIRECT SPECIMEN TEST KIT

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.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.

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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