FDA 510(k)

Vitek Densichek

K-Number: K192110 · 2019-10-31

Decision Date2019-10-31

Product CodeLON

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Vitek Densichek is a medical device manufactured by bioMerieux, Inc.. It received FDA 510(k) clearance on 2019-10-31 under approval number K192110. 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 Densichek?

Vitek Densichek is a medical device that received FDA 510(k) clearance on 2019-10-31. It is manufactured by bioMerieux, Inc.. The 510(k) number is K192110.

When was Vitek Densichek approved by the FDA?

Vitek Densichek received FDA 510(k) clearance on 2019-10-31, under approval number K192110.

What company makes Vitek Densichek?

Vitek Densichek is manufactured by bioMerieux, Inc..

What is the FDA product code for Vitek Densichek?

The FDA product code for Vitek Densichek is LON.

Other Devices by bioMerieux, Inc.

K162076chromID MRSA K161227VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL) K160911VIDAS B.R.A.H.M.S. PCT (PCT) K152075VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL) K151923VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) K151688chromID MRSA

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Related Devices (Code: LON)

K161227VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL)bioMerieux, Inc. K152075VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL)bioMerieux, Inc. K151320BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/mlBecton, Dickinson and Company K172944VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 >=16 µg/mLbioMerieux, Inc. K172731VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)bioMerieux, Inc. K162737VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4µg/mL)bioMerieux, 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.