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FDA 510(k)

PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY

K-Number: K964864 · 1997-02-04

ApplicantAlexon Biomedical, Inc.
Decision Date1997-02-04
Product CodeLLH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Alexon Biomedical, Inc.. It received FDA 510(k) clearance on 1997-02-04 under 510(k) number K964864. 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 II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY?

PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY is a medical device that received FDA 510(k) clearance on 1997-02-04. The listed applicant is Alexon Biomedical, Inc.. The 510(k) number is K964864.

When did PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY receive FDA 510(k) clearance?

PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY received FDA 510(k) clearance on 1997-02-04, under 510(k) number K964864.

Who is the listed applicant for PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY?

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

What is the FDA product code for PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY?

The FDA product code for PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY is LLH.

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Other records listing Alexon Biomedical, 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.

K955157PROSPECT GIARDIA/CRYPTOSPORIDIUM MICROPLATE ASSAYK936191PROSPECT CRYPTOSPORIDIUM RAPID ASSAYK933997PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAYK874849PROSPECT/GIARDIA

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

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