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FDA 510(k)

DENSICHECK PLUS

K-Number: K093224 · 2009-11-09

ApplicantbioMerieux, Inc.
Decision Date2009-11-09
Product CodeLON
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DENSICHECK PLUS is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2009-11-09 under 510(k) number K093224. 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 DENSICHECK PLUS?

DENSICHECK PLUS is a medical device that received FDA 510(k) clearance on 2009-11-09. The listed applicant is bioMerieux, Inc.. The 510(k) number is K093224.

When did DENSICHECK PLUS receive FDA 510(k) clearance?

DENSICHECK PLUS received FDA 510(k) clearance on 2009-11-09, under 510(k) number K093224.

Who is the listed applicant for DENSICHECK PLUS?

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 DENSICHECK PLUS?

The FDA product code for DENSICHECK PLUS is LON.

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Other records listing bioMerieux, Inc. as applicant

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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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