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FDA 510(k)

LMD GIARDIA ANTIGEN DETECTION ASSAY

K-Number: K944871 · 1995-06-22

ApplicantLmd Laboratories
Decision Date1995-06-22
Product CodeMHI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LMD GIARDIA ANTIGEN DETECTION ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Lmd Laboratories. It received FDA 510(k) clearance on 1995-06-22 under 510(k) number K944871. 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 LMD GIARDIA ANTIGEN DETECTION ASSAY?

LMD GIARDIA ANTIGEN DETECTION ASSAY is a medical device that received FDA 510(k) clearance on 1995-06-22. The listed applicant is Lmd Laboratories. The 510(k) number is K944871.

When did LMD GIARDIA ANTIGEN DETECTION ASSAY receive FDA 510(k) clearance?

LMD GIARDIA ANTIGEN DETECTION ASSAY received FDA 510(k) clearance on 1995-06-22, under 510(k) number K944871.

Who is the listed applicant for LMD GIARDIA ANTIGEN DETECTION ASSAY?

The FDA 510(k) record lists Lmd Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LMD GIARDIA ANTIGEN DETECTION ASSAY?

The FDA product code for LMD GIARDIA ANTIGEN DETECTION ASSAY is MHI.

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Other records listing Lmd Laboratories 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.

K955345LMD CRYPTOSPORIDIUM ANTIGEN DETECTIONK942705E. COLI 0157 ELISA STOOL ASSAYK905598CRYPTOSPORIDIUM ANTIGEN DETECTIONK904613TRICHINELLA SEROLOGY MICROTITER ELISAK900780CYSTICERCOSIS SEROLOGICAL REAGENTSK890003GIARDIA STOOL ANTIGEN TEST KIT

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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

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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