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FDA 510(k)

MERIFLUOR(TM) -TRICHOMONAS

K-Number: K892263 · 1989-05-24

ApplicantMeridian Diagnostics, Inc.
Decision Date1989-05-24
Product CodeJWZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MERIFLUOR(TM) -TRICHOMONAS is the device name listed in this FDA 510(k) record. The listed applicant is Meridian Diagnostics, Inc.. It received FDA 510(k) clearance on 1989-05-24 under 510(k) number K892263. 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 MERIFLUOR(TM) -TRICHOMONAS?

MERIFLUOR(TM) -TRICHOMONAS is a medical device that received FDA 510(k) clearance on 1989-05-24. The listed applicant is Meridian Diagnostics, Inc.. The 510(k) number is K892263.

When did MERIFLUOR(TM) -TRICHOMONAS receive FDA 510(k) clearance?

MERIFLUOR(TM) -TRICHOMONAS received FDA 510(k) clearance on 1989-05-24, under 510(k) number K892263.

Who is the listed applicant for MERIFLUOR(TM) -TRICHOMONAS?

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

What is the FDA product code for MERIFLUOR(TM) -TRICHOMONAS?

The FDA product code for MERIFLUOR(TM) -TRICHOMONAS is JWZ.

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Other records listing Meridian 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.

K993914PREMIER TOXINS A&B, MODEL 616096K990263IMMUNOCARD STAT! E. COLI O157:H7K984343PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TESTK984346PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TESTK983255MODIFICATION TO: PREMIER PLATINUM HPSAK982764PREMIER CRYPTOSPORIDIUM

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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.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.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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