Clarithromycin 15mcg Sensi Disc

• • Ongoing Z-1028-2024 FDA Class II ·initiated 8 Jan 2024

  There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.

510(k) Number

K920131 ↗

FDA Product Code

JTN

Device Class

Class II

Regulation

21 CFR Part 866.1620

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K854093 Active Cleared 12 Nov 1985

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  FDA 510(k) K874427 Active Cleared 5 Jan 1988

• Sensicare Synthetic Medical Gloves

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  FDA 510(k) K915478 Active Cleared 27 Jan 1992

• Qbc Centrifugal Hematology Analyzer

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  Class I

  FDA 510(k) K771582 Active Cleared 13 Sep 1977

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  FDA 510(k) K802136 Active Cleared 10 Oct 1980

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