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FDA 510(k)

SUPER DUO

K-Number: K892802 · 1989-06-13

ApplicantMercia Diagnostics , Ltd.
Decision Date1989-06-13
Product CodeJWZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SUPER DUO is the device name listed in this FDA 510(k) record. The listed applicant is Mercia Diagnostics , Ltd.. It received FDA 510(k) clearance on 1989-06-13 under 510(k) number K892802. 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 SUPER DUO?

SUPER DUO is a medical device that received FDA 510(k) clearance on 1989-06-13. The listed applicant is Mercia Diagnostics , Ltd.. The 510(k) number is K892802.

When did SUPER DUO receive FDA 510(k) clearance?

SUPER DUO received FDA 510(k) clearance on 1989-06-13, under 510(k) number K892802.

Who is the listed applicant for SUPER DUO?

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

What is the FDA product code for SUPER DUO?

The FDA product code for SUPER DUO is JWZ.

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Other records listing Mercia Diagnostics , Ltd. as applicant

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K915479CAPTIA CMV-TAK904524CAPTIA(R) SYPHILIS M, MODIFICATIONK900654MODIFIED CAPTIA(R) SYPHILIS-MK896295CAPTIA(R) CMV-MK900655MODIFIED CAPTIA(R) TOXO-MK896194CAPTIA(R) CMV-G

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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.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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