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

FDA 510(k)

Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml

K-Number: K153569 · 2016-06-22

ApplicantLiofilchem s.r.l.
Decision Date2016-06-22
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml is a medical device manufactured by Liofilchem s.r.l.. It received FDA 510(k) clearance on 2016-06-22 under approval number K153569. The device is classified under product code JWY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml?

Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml is a medical device that received FDA 510(k) clearance on 2016-06-22. It is manufactured by Liofilchem s.r.l.. The 510(k) number is K153569.

When was Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml approved by the FDA?

Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml received FDA 510(k) clearance on 2016-06-22, under approval number K153569.

What company makes Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml?

Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml is manufactured by Liofilchem s.r.l..

What is the FDA product code for Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml?

The FDA product code for Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml is JWY.

Other Devices by Liofilchem s.r.l.

K162854Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/ml K161175Liofilchem MIC Test Strip (MTS)- Ceftolozane/Tazobactam 0.016/4 - 256/4 mcg/mL K153687Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL K173307Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 µg/mL K172542Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 mg/mL. K172109Liofilchem MIC Test Strip (MTS), Erythromycin 0.016 - 256 µg/mL

View all 35 devices →

Related Devices (Code: JWY)

K162854Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/mlLiofilchem s.r.l. K161175Liofilchem MIC Test Strip (MTS)- Ceftolozane/Tazobactam 0.016/4 - 256/4 mcg/mLLiofilchem s.r.l. K153687Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mLLiofilchem s.r.l. K173307Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 µg/mLLiofilchem s.r.l. K173209Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Meropenem/Vaborbactam in the Dilution Range of 0.008/8 - 18/8 ug/mLThermo Fisher Scientific K172542Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 mg/mL.Liofilchem s.r.l.

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.

↑