Microscan Microstrep Plus Panel Cefaclor (0.5 - 8 Mcg/Ml)

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K063102 ↗

FDA Product Code

LRG

Device Class

Class II

Regulation

21 CFR Part 866.1640

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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• What is the primary purpose of the Microscan Microstrep Plus Panel?

  This panel is designed for the automated reading and interpretation of overnight susceptibility systems. It allows microbiology laboratories to determine both the quantitative and qualitative antimicrobial agent susceptibility of aerobic streptococci colonies that have been grown on solid media.

• What concentration range of Cefaclor is provided in this panel?

  The Microscan Microstrep Plus Panel contains the antimicrobial agent Cefaclor in a concentration range of 0.5 to 8 mcg/ml, which is used to assess the susceptibility of the bacterial colonies being tested.

• What is the regulatory status of this device?

  The Microscan Microstrep Plus Panel Cefaclor is regulated under FDA 510K clearance. It was reviewed under the microbiology advisory committee and received a decision of substantial equivalence, confirming it meets the necessary standards for use in clinical microbiology settings.