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FDA 510(k)

VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE

K-Number: K103752 · 2011-10-14

ApplicantbioMerieux, Inc.
Decision Date2011-10-14
Product CodeLON
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2011-10-14 under 510(k) number K103752. The device is classified under product code LON. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE?

VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE is a medical device that received FDA 510(k) clearance on 2011-10-14. The listed applicant is bioMerieux, Inc.. The 510(k) number is K103752.

When did VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE receive FDA 510(k) clearance?

VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE received FDA 510(k) clearance on 2011-10-14, under 510(k) number K103752.

Who is the listed applicant for VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE?

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

What is the FDA product code for VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE?

The FDA product code for VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE is LON.

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Other records listing bioMerieux, 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.

K260160VITEK REVEAL GN AST Assay and VITEK REVEAL AST SystemK260282VITEK 2 AST-Streptococcus Inducible Clindamycin ResistanceK251579VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)K234012VITEK COMPACT PROK232967VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)K232963VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)

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Related Devices (Code: LON)

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.

K260282VITEK 2 AST-Streptococcus Inducible Clindamycin ResistancebioMerieux, Inc.K260281VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)BIOMERIEUXK251579VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)bioMerieux, Inc.K251713BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)Becton, Dickinson and CompanyK250447BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)Becton, Dickinson and CompanyK234012VITEK COMPACT PRObioMerieux, 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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