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FDA 510(k)

TREND GIARDIA LAMBLIA DIRECT DETECTION SYSTEM (MODIFIED KIT)

K-Number: K952467 · 1995-11-20

ApplicantTrend Scientific, Inc.
Decision Date1995-11-20
Product CodeMHI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TREND GIARDIA LAMBLIA DIRECT DETECTION SYSTEM (MODIFIED KIT) 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 1995-11-20 under 510(k) number K952467. The device is classified under product code MHI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TREND GIARDIA LAMBLIA DIRECT DETECTION SYSTEM (MODIFIED KIT)?

TREND GIARDIA LAMBLIA DIRECT DETECTION SYSTEM (MODIFIED KIT) is a medical device that received FDA 510(k) clearance on 1995-11-20. The listed applicant is Trend Scientific, Inc.. The 510(k) number is K952467.

When did TREND GIARDIA LAMBLIA DIRECT DETECTION SYSTEM (MODIFIED KIT) receive FDA 510(k) clearance?

TREND GIARDIA LAMBLIA DIRECT DETECTION SYSTEM (MODIFIED KIT) received FDA 510(k) clearance on 1995-11-20, under 510(k) number K952467.

Who is the listed applicant for TREND GIARDIA LAMBLIA DIRECT DETECTION SYSTEM (MODIFIED KIT)?

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 GIARDIA LAMBLIA DIRECT DETECTION SYSTEM (MODIFIED KIT)?

The FDA product code for TREND GIARDIA LAMBLIA DIRECT DETECTION SYSTEM (MODIFIED KIT) is MHI.

Related Clinical Trials

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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.

K954996TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEMK955755TREND CRYPTOSPORIDIUM DETECTION TEST SYSTEMSK953284TREND GIARDIA DIRECT DETECTION RS TEST SYSTEMK862914FEKAL CHECK PARASITOLOGY CONTROL SLIDEK830769FEKAL CON-TRATE SYSTEM

Related Devices (Code: MHI)

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.

K120001UNIGOLD GIARDIATrinity BiotechK103673GIARDIA/ CRYPTOSPORIDIUM QUIK CHEKTechlab Inc., Corporate Research CenterK081064GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LFIvd Research, Inc.K031942XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020Remel, Inc.K031834XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAYRemel, Inc.K033274GIARDIA IITechlab, 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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