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FDA 510(k)

PROSPECT(TM) GIARDIA RAPID ASSAY

K-Number: K915093 · 1992-01-30

ApplicantAlexon, Inc.
Decision Date1992-01-30
Product CodeMHI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PROSPECT(TM) GIARDIA RAPID ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Alexon, Inc.. It received FDA 510(k) clearance on 1992-01-30 under 510(k) number K915093. 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 PROSPECT(TM) GIARDIA RAPID ASSAY?

PROSPECT(TM) GIARDIA RAPID ASSAY is a medical device that received FDA 510(k) clearance on 1992-01-30. The listed applicant is Alexon, Inc.. The 510(k) number is K915093.

When did PROSPECT(TM) GIARDIA RAPID ASSAY receive FDA 510(k) clearance?

PROSPECT(TM) GIARDIA RAPID ASSAY received FDA 510(k) clearance on 1992-01-30, under 510(k) number K915093.

Who is the listed applicant for PROSPECT(TM) GIARDIA RAPID ASSAY?

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

What is the FDA product code for PROSPECT(TM) GIARDIA RAPID ASSAY?

The FDA product code for PROSPECT(TM) GIARDIA RAPID ASSAY is MHI.

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Other records listing Alexon, 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.

K934493PROSPECT MICROPLATE ASSAYK942098PROSPECT GIARDIAK931147PROSPECT(TM) GIARDIA RAPID ASSAY, MODIFICATIONK930451PROSPEC T GIARDIA MICROTITER ASSAYK922675PROSPECT GIARDIA CONTROLSK922010PROSPECT(TM) GIARDIA MICROTITER ASSAY/MODIFICATION

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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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