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FDA 510(k)

PROSPEC T/GIARDIA RAPID ASSAY

K-Number: K911337 · 1991-09-27

ApplicantAlexon, Inc.
Decision Date1991-09-27
Product CodeMHI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PROSPEC T/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 1991-09-27 under 510(k) number K911337. 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 PROSPEC T/GIARDIA RAPID ASSAY?

PROSPEC T/GIARDIA RAPID ASSAY is a medical device that received FDA 510(k) clearance on 1991-09-27. The listed applicant is Alexon, Inc.. The 510(k) number is K911337.

When did PROSPEC T/GIARDIA RAPID ASSAY receive FDA 510(k) clearance?

PROSPEC T/GIARDIA RAPID ASSAY received FDA 510(k) clearance on 1991-09-27, under 510(k) number K911337.

Who is the listed applicant for PROSPEC T/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 PROSPEC T/GIARDIA RAPID ASSAY?

The FDA product code for PROSPEC T/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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