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FDA 510(k)

XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY

K-Number: K031834 · 2003-11-10

ApplicantRemel, Inc.
Decision Date2003-11-10
Product CodeMHI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Remel, Inc.. It received FDA 510(k) clearance on 2003-11-10 under 510(k) number K031834. 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 XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY?

XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY is a medical device that received FDA 510(k) clearance on 2003-11-10. The listed applicant is Remel, Inc.. The 510(k) number is K031834.

When did XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY receive FDA 510(k) clearance?

XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY received FDA 510(k) clearance on 2003-11-10, under 510(k) number K031834.

Who is the listed applicant for XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY?

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

What is the FDA product code for XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY?

The FDA product code for XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY is MHI.

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Other records listing Remel, 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.

K162620Remel Spectra ESBLK131804REMEL XPECT FLU A&BK092407REMEL SPECTRA MRSAK072827RPMI 1640 AGAR W/MOPS AND 2% GLUCOSEK041951XPECT CLOSTRIDIUM DIFFICILE TOXIN A/BK033479PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY

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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.K033274GIARDIA IITechlab, Inc.K024113IVD CRYPTO/GIARDIA DFAIvd Research, 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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