Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

VITEK GRAM POSITIVE SUSCEPTIBILITY DAPTOMYCIN

K-Number: K052656 · 2005-11-07

ApplicantbioMerieux, Inc.
Decision Date2005-11-07
Product CodeLON
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VITEK GRAM POSITIVE SUSCEPTIBILITY DAPTOMYCIN is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2005-11-07 under 510(k) number K052656. 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 GRAM POSITIVE SUSCEPTIBILITY DAPTOMYCIN?

VITEK GRAM POSITIVE SUSCEPTIBILITY DAPTOMYCIN is a medical device that received FDA 510(k) clearance on 2005-11-07. The listed applicant is bioMerieux, Inc.. The 510(k) number is K052656.

When did VITEK GRAM POSITIVE SUSCEPTIBILITY DAPTOMYCIN receive FDA 510(k) clearance?

VITEK GRAM POSITIVE SUSCEPTIBILITY DAPTOMYCIN received FDA 510(k) clearance on 2005-11-07, under 510(k) number K052656.

Who is the listed applicant for VITEK GRAM POSITIVE SUSCEPTIBILITY DAPTOMYCIN?

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 GRAM POSITIVE SUSCEPTIBILITY DAPTOMYCIN?

The FDA product code for VITEK GRAM POSITIVE SUSCEPTIBILITY DAPTOMYCIN is LON.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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)

View all 248 devices →

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.

↑