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FDA 510(k)

XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B

K-Number: K041951 · 2004-11-15

ApplicantRemel, Inc.
Decision Date2004-11-15
Product CodeLLH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B is the device name listed in this FDA 510(k) record. The listed applicant is Remel, Inc.. It received FDA 510(k) clearance on 2004-11-15 under 510(k) number K041951. 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 XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B?

XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B is a medical device that received FDA 510(k) clearance on 2004-11-15. The listed applicant is Remel, Inc.. The 510(k) number is K041951.

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

XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B received FDA 510(k) clearance on 2004-11-15, under 510(k) number K041951.

Who is the listed applicant for XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B?

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 CLOSTRIDIUM DIFFICILE TOXIN A/B?

The FDA product code for XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B 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% GLUCOSEK033479PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAYK031942XPECT 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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