Dispens-O-Disc Levofloxacin

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

Full name

Dispens-O-Disc (Tm) Levofloxacin

510(k) Number

K971120 ↗

FDA Product Code

JTN

Device Class

Class II

Regulation

21 CFR Part 866.1620

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Differentiation Disks Vancomycin 5 Mcg

  Class I

  FDA 510(k) K860563 Active Cleared 11 Mar 1986

• Dispens-O-Disc(Tm) Nitrocefin

  Class I

  FDA 510(k) K941016 Active Cleared 30 Jun 1994

• Differentiation Disks Bile Esculin

  Class I

  FDA 510(k) K843364 Active Cleared 7 Sep 1984

• Spottest Voges-Proskauer Reagent a

  Class I

  FDA 510(k) K840578 Active Cleared 27 Feb 1984

• Toxo-Cube

  Class II

  FDA 510(k) K903968 Active Cleared 18 Dec 1990

• Broth Elution Disks Clindamycin 10mcg

  Class II

  FDA 510(k) K870175 Active Cleared 29 Apr 1987

See all devices from Difco Laboratories, Inc. →

• What is the Dispens-O-Disc Levofloxacin used for?

  The Dispens-O-Disc Levofloxacin is used to determine the susceptibility of microorganisms to levofloxacin in laboratory settings.

• Is the Dispens-O-Disc Levofloxacin a single-use device?

  The Dispens-O-Disc Levofloxacin is a single product, but its single-use or reuse status is determined by standard laboratory protocols.

• How is the Dispens-O-Disc Levofloxacin regulated?

  The Dispens-O-Disc Levofloxacin is regulated under the FDA with a clearance type of Traditional 510(k) and has a product code of JTN.

• What is the storage and handling procedure for the Dispens-O-Disc Levofloxacin?

  The Dispens-O-Disc Levofloxacin is stored and used according to standard laboratory protocols.