FDA 510(k)

VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN

K-Number: K112129 · 2011-09-27

Decision Date2011-09-27

Product CodeLON

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2011-09-27 under 510(k) number K112129. 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(R) 2 STREPTOCOCCUS CLINDAMYCIN?

VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN is a medical device that received FDA 510(k) clearance on 2011-09-27. The listed applicant is bioMerieux, Inc.. The 510(k) number is K112129.

When did VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN receive FDA 510(k) clearance?

VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN received FDA 510(k) clearance on 2011-09-27, under 510(k) number K112129.

Who is the listed applicant for VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN?

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(R) 2 STREPTOCOCCUS CLINDAMYCIN?

The FDA product code for VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN is LON.

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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.