Micur-Mic Systems

No FDA recalls found in the data synced 6 Oct 2026.

Generic Name

SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

PMA Number

P820073 ↗

FDA Product Code

LON

Device Class

Class II

Regulation

21 CFR Part 866.1645

Advisory Committee

Microbiology

FDA Decision

APRL

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• What is the primary purpose of the Micur-Mic Systems in a clinical setting, and how does it improve workflow efficiency?

  The Micur-Mic Systems automates the determination of antimicrobial susceptibility for microorganisms, enabling faster and more standardized testing with shorter incubation times. This helps clinicians make quicker, data-driven decisions in managing infectious diseases, reducing turnaround time for critical results while maintaining accuracy.

• Is the Micur-Mic Systems designed for single-use or repeated use in a laboratory environment?

  The Micur-Mic Systems is explicitly described as a reusable device, meaning it is built for repeated use in clinical microbiology laboratories under controlled conditions to ensure consistent and reliable antimicrobial susceptibility testing.

• What regulatory pathway was followed for the approval of the Micur-Mic Systems, and which federal code governs its classification?

  The Micur-Mic Systems received FDA Premarket Approval (PMA) under the designation P820073, confirming its compliance with regulatory standards. It is classified under 21 CFR 866.1645 and falls under Class II medical devices, as outlined in the submission records.

• How does the Micur-Mic Systems support clinical decision-making in infectious disease management?

  By automating antimicrobial susceptibility testing, the Micur-Mic Systems provides rapid and standardized results with reduced incubation times. This accelerates diagnostic clarity, allowing clinicians to tailor antibiotic treatments more effectively and efficiently for patients with infectious diseases.