When did VITEK 2 AST-Gram Negative Omadacycline ( =16 µg/mL) receive FDA 510(k) clearance?

VITEK 2 AST-Gram Negative Omadacycline ( =16 µg/mL) received FDA 510(k) clearance on 2022-06-03, under 510(k) number K213931.

FDA 510(k)

VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)

K-Number: K213931 · 2022-06-03

ApplicantbioMerieux, Inc.

Decision Date2022-06-03

Product CodeLON

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL) is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2022-06-03 under 510(k) number K213931. 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 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)?

VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL) is a medical device that received FDA 510(k) clearance on 2022-06-03. The listed applicant is bioMerieux, Inc.. The 510(k) number is K213931.

When did VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL) receive FDA 510(k) clearance?

VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL) received FDA 510(k) clearance on 2022-06-03, under 510(k) number K213931.

Who is the listed applicant for VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)?

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 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)?

The FDA product code for VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL) is LON.

Related PubMed Literature

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.

PMID: 37162363Multicenter Clinical Performance Evaluation of Omadacycline Susceptibility Testing of Enterobacterales on VITEK 2 Systems.Journal of clinical microbiology (2023)

Other records listing bioMerieux, Inc. as applicant

K260160VITEK REVEAL GN AST Assay and VITEK REVEAL AST System K260282VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance K260281VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)K251579VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)K234012VITEK COMPACT PRO K232967VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)

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Related Devices (Code: LON)

K260282VITEK 2 AST-Streptococcus Inducible Clindamycin ResistancebioMerieux, Inc.K260281VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)BIOMERIEUX K251579VITEK 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 Company K250447BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)Becton, Dickinson and Company K234012VITEK 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.