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FDA 510(k)

OSOM C. DIFFICILE TOXIN A/B TEST

K-Number: K102242 · 2010-12-21

ApplicantGenzyme Corporation
Decision Date2010-12-21
Product CodeLLH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

OSOM C. DIFFICILE TOXIN A/B TEST is the device name listed in this FDA 510(k) record. The listed applicant is Genzyme Corporation. It received FDA 510(k) clearance on 2010-12-21 under 510(k) number K102242. 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 OSOM C. DIFFICILE TOXIN A/B TEST?

OSOM C. DIFFICILE TOXIN A/B TEST is a medical device that received FDA 510(k) clearance on 2010-12-21. The listed applicant is Genzyme Corporation. The 510(k) number is K102242.

When did OSOM C. DIFFICILE TOXIN A/B TEST receive FDA 510(k) clearance?

OSOM C. DIFFICILE TOXIN A/B TEST received FDA 510(k) clearance on 2010-12-21, under 510(k) number K102242.

Who is the listed applicant for OSOM C. DIFFICILE TOXIN A/B TEST?

The FDA 510(k) record lists Genzyme Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OSOM C. DIFFICILE TOXIN A/B TEST?

The FDA product code for OSOM C. DIFFICILE TOXIN A/B TEST is LLH.

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Other records listing Genzyme Corporation 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.

K092633OSOM INFLUENZA A&B TEST , MODEL PN190K080662GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATORK063739SEPRAMESH, MODEL 5959-1214K053066SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESHK043035SEPRAGEL ENT BIORESORBABLE PACKING/STENT

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.K091109XPERT C. DIFFICILECepheidK090239PROGASTRO CD ASSAYProdesse, Inc.K082499C. DIFF QUIK CHEK COMPLETETechlab, Inc.K081920BD GENEOHM CDIFF ASSAYBd Diagnostics (Geneohm Sciences, Inc.)K080931VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAYbioMerieux, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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