Synercid, 15 Ug, Bbl Sensi-Disc

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

510(k) Number

K993186 ↗

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 Synercid 15 ug BBL Sensi-Disc used for?

  This device is a susceptibility test disc used for microbiology testing to determine bacterial susceptibility to the antimicrobial agent Synercid (quinupristin/dalfopristin) in vitro, aiding clinical laboratories in guiding antibiotic therapy decisions based on laboratory results.

• How is the Synercid 15 ug BBL Sensi-Disc supplied and is it sterile or reusable?

  The disc is supplied as a sterile, single-use product designed for one-time application in laboratory testing; it is not intended for reuse due to the risk of contamination and compromised test accuracy after initial use.

• What is the concentration of Synercid in each disc and what format does it use?

  Each disc contains 15 micrograms of Synercid (quinupristin/dalfopristin) and is formatted as a BBL Sensi-Disc, a standardized paper disc format used in disk diffusion susceptibility testing methods.

• What regulatory pathway was used for the Synercid 15 ug BBL Sensi-Disc and what is its device classification?

  The device received FDA 510(k) clearance under K993186 as a Class II medical device, determined to be substantially equivalent to a legally marketed predicate device for antimicrobial susceptibility testing.