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FDA 510(k)

IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96

K-Number: K020583 · 2002-09-17

ApplicantIvd Research, Inc.
Decision Date2002-09-17
Product CodeMHI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96 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 2002-09-17 under 510(k) number K020583. 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 IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96?

IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96 is a medical device that received FDA 510(k) clearance on 2002-09-17. The listed applicant is Ivd Research, Inc.. The 510(k) number is K020583.

When did IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96 receive FDA 510(k) clearance?

IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96 received FDA 510(k) clearance on 2002-09-17, under 510(k) number K020583.

Who is the listed applicant for IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96?

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 IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96?

The FDA product code for IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96 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.

K081064GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LFK032897C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL; CDIFF-96K031059IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96K024113IVD CRYPTO/GIARDIA DFA

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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