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FDA 510(k)

GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF

K-Number: K081064 · 2009-01-14

ApplicantIvd Research, Inc.
Decision Date2009-01-14
Product CodeMHI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF is the device name listed in this FDA 510(k) record. The listed applicant is Ivd Research, Inc.. It received FDA 510(k) clearance on 2009-01-14 under 510(k) number K081064. 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 GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF?

GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF is a medical device that received FDA 510(k) clearance on 2009-01-14. The listed applicant is Ivd Research, Inc.. The 510(k) number is K081064.

When did GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF receive FDA 510(k) clearance?

GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF received FDA 510(k) clearance on 2009-01-14, under 510(k) number K081064.

Who is the listed applicant for GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF?

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

What is the FDA product code for GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF?

The FDA product code for GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF is MHI.

Related Clinical Trials

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.

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Other records listing Ivd Research, 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.

K032897C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL; CDIFF-96K031059IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96K024113IVD CRYPTO/GIARDIA DFAK020583IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96

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 CenterK031942XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020Remel, Inc.K031834XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAYRemel, Inc.K033274GIARDIA IITechlab, Inc.K024113IVD CRYPTO/GIARDIA DFAIvd Research, 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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