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FDA 510(k)

MODIFIED TRICHOMONAS DIRECT SPECIMEN TEST KIT

K-Number: K871279 · 1987-04-08

ApplicantCalifornia Integrated Diagnostics, Inc.
Decision Date1987-04-08
Product CodeJWZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MODIFIED TRICHOMONAS DIRECT SPECIMEN TEST KIT 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 1987-04-08 under 510(k) number K871279. 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 MODIFIED TRICHOMONAS DIRECT SPECIMEN TEST KIT?

MODIFIED TRICHOMONAS DIRECT SPECIMEN TEST KIT is a medical device that received FDA 510(k) clearance on 1987-04-08. The listed applicant is California Integrated Diagnostics, Inc.. The 510(k) number is K871279.

When did MODIFIED TRICHOMONAS DIRECT SPECIMEN TEST KIT receive FDA 510(k) clearance?

MODIFIED TRICHOMONAS DIRECT SPECIMEN TEST KIT received FDA 510(k) clearance on 1987-04-08, under 510(k) number K871279.

Who is the listed applicant for MODIFIED TRICHOMONAS DIRECT SPECIMEN TEST KIT?

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 MODIFIED TRICHOMONAS DIRECT SPECIMEN TEST KIT?

The FDA product code for MODIFIED TRICHOMONAS DIRECT SPECIMEN TEST KIT 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. TYPINGK874259TRICHOMONAS DIRECT ENZYME IMMUNOASSAYK871278MODIFIED CHLAMYDIA 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

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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