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FDA 510(k)

PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY

K-Number: K033479 · 2004-02-26

ApplicantRemel, Inc.
Decision Date2004-02-26
Product CodeLLH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE 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 2004-02-26 under 510(k) number K033479. The device is classified under product code LLH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY?

PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY is a medical device that received FDA 510(k) clearance on 2004-02-26. The listed applicant is Remel, Inc.. The 510(k) number is K033479.

When did PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY receive FDA 510(k) clearance?

PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY received FDA 510(k) clearance on 2004-02-26, under 510(k) number K033479.

Who is the listed applicant for PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE 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 PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY?

The FDA product code for PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY is LLH.

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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/BK031942XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020

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Related Devices (Code: LLH)

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.

K193490SensiTox C. difficile Toxin TestFirst Light Diagnostics, Inc.K102242OSOM C. DIFFICILE TOXIN A/B TESTGenzyme CorporationK091109XPERT C. DIFFICILECepheidK090239PROGASTRO CD ASSAYProdesse, Inc.K082499C. DIFF QUIK CHEK COMPLETETechlab, Inc.K081920BD GENEOHM CDIFF ASSAYBd Diagnostics (Geneohm Sciences, 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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