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FDA 510(k)

BD GENEOHM CDIFF ASSAY

K-Number: K081920 · 2008-12-19

ApplicantBd Diagnostics (Geneohm Sciences, Inc.)
Decision Date2008-12-19
Product CodeLLH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BD GENEOHM CDIFF ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Bd Diagnostics (Geneohm Sciences, Inc.). It received FDA 510(k) clearance on 2008-12-19 under 510(k) number K081920. 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 BD GENEOHM CDIFF ASSAY?

BD GENEOHM CDIFF ASSAY is a medical device that received FDA 510(k) clearance on 2008-12-19. The listed applicant is Bd Diagnostics (Geneohm Sciences, Inc.). The 510(k) number is K081920.

When did BD GENEOHM CDIFF ASSAY receive FDA 510(k) clearance?

BD GENEOHM CDIFF ASSAY received FDA 510(k) clearance on 2008-12-19, under 510(k) number K081920.

Who is the listed applicant for BD GENEOHM CDIFF ASSAY?

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

What is the FDA product code for BD GENEOHM CDIFF ASSAY?

The FDA product code for BD GENEOHM CDIFF ASSAY is LLH.

Related Clinical Trials

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Other records listing Bd Diagnostics (Geneohm Sciences, 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.

K093346BD GENEOHM MRSA ACP ASSAY

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.K080931VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAYbioMerieux, 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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