Norfloxacin 10 Mcg Sensi Disc

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

510(k) Number

K864756 ↗

FDA Product Code

JTN

Device Class

Class II

Regulation

21 CFR Part 866.1620

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Leuco Prep

  Class I

  FDA 510(k) K854093 Active Cleared 12 Nov 1985

• Qbc System Hemoglobin

  Class II

  FDA 510(k) K874427 Active Cleared 5 Jan 1988

• Sensicare Synthetic Medical Gloves

  Class I

  FDA 510(k) K915478 Active Cleared 27 Jan 1992

• Qbc Centrifugal Hematology Analyzer

  Class II

  FDA 510(k) K844645 Active Cleared 5 Mar 1985

• Holesterol Delta Test Assay

  Class I

  FDA 510(k) K771582 Active Cleared 13 Sep 1977

• Delta Test Triglycerides

  Class I

  FDA 510(k) K802136 Active Cleared 10 Oct 1980

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• What is the Norfloxacin 10 mcg Sensi Disc used for?

  It is used to determine the susceptibility of microorganisms to norfloxacin in laboratory testing, helping clinicians assess whether bacteria are likely to respond to this antibiotic based on in vitro results.

• How is the Norfloxacin 10 mcg Sensi Disc supplied and is it reusable?

  The device is supplied as a sterile, single-use disc, meaning each disc is intended for one test only and must be discarded after use to prevent contamination and ensure accurate results.

• What regulatory pathway and classification apply to the Norfloxacin 10 mcg Sensi Disc?

  It is classified as a Class 2 device under regulation number 866.1620 with product code JTN and received FDA 510(k) clearance K864756 through the traditional 510(k) pathway as substantially equivalent to a predicate device.