FDA 510(k)

VITEK COMPACT PRO

K-Number: K234012 · 2025-03-14

Decision Date2025-03-14

Product CodeLON

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

VITEK COMPACT PRO is a medical device manufactured by bioMerieux, Inc.. It received FDA 510(k) clearance on 2025-03-14 under approval number K234012. 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 COMPACT PRO?

VITEK COMPACT PRO is a medical device that received FDA 510(k) clearance on 2025-03-14. It is manufactured by bioMerieux, Inc.. The 510(k) number is K234012.

When was VITEK COMPACT PRO approved by the FDA?

VITEK COMPACT PRO received FDA 510(k) clearance on 2025-03-14, under approval number K234012.

What company makes VITEK COMPACT PRO?

VITEK COMPACT PRO is manufactured by bioMerieux, Inc..

What is the FDA product code for VITEK COMPACT PRO?

The FDA product code for VITEK COMPACT PRO 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.