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FDA 510(k)

TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM

K-Number: K954996 · 1996-08-08

ApplicantTrend Scientific, Inc.
Decision Date1996-08-08
Product CodeKHW
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Trend Scientific, Inc.. It received FDA 510(k) clearance on 1996-08-08 under 510(k) number K954996. The device is classified under product code KHW. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM?

TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1996-08-08. The listed applicant is Trend Scientific, Inc.. The 510(k) number is K954996.

When did TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM receive FDA 510(k) clearance?

TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM received FDA 510(k) clearance on 1996-08-08, under 510(k) number K954996.

Who is the listed applicant for TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM?

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

What is the FDA product code for TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM?

The FDA product code for TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM is KHW.

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Other records listing Trend Scientific, 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.

K955755TREND CRYPTOSPORIDIUM DETECTION TEST SYSTEMSK952467TREND GIARDIA LAMBLIA DIRECT DETECTION SYSTEM (MODIFIED KIT)K953284TREND GIARDIA DIRECT DETECTION RS TEST SYSTEMK862914FEKAL CHECK PARASITOLOGY CONTROL SLIDEK830769FEKAL CON-TRATE SYSTEM

Related Devices (Code: KHW)

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.

K170728E. HISTOLYTICA QUIK CHEKTechlab, Inc.K994101E. HISTOLYTICA IITechlab, Inc.K955895E. HISTOLYTICA TESTTechlab, Inc.K944791ENTAMOEBA TESTTechlab, Inc.K900604DIRECT FLUORESCENT ANTIBODY REAGENT FOR GIARDIABiovir Laboratories, Inc.K890774GIARDEIA(TM)Antibodies, 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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