Augmentin 30 mcg Sensitivity Discs

No FDA recalls on record, checked 5 Oct 2026.

Full name

Augmentin 30 Mcg Sensitivity Disks

510(k) Number

K843172 ↗

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) K860563 Active Cleared 11 Mar 1986

• Dispens-O-Disc(Tm) Nitrocefin

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  FDA 510(k) K941016 Active Cleared 30 Jun 1994

• Differentiation Disks Bile Esculin

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  FDA 510(k) K843364 Active Cleared 7 Sep 1984

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  FDA 510(k) K903968 Active Cleared 18 Dec 1990

• Broth Elution Disks Clindamycin 10mcg

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  FDA 510(k) K870175 Active Cleared 29 Apr 1987

See all devices from Difco Laboratories, Inc. →

• What is the purpose of the Augmentin 30 mcg Sensitivity Discs?

  These discs are designed for microbiological testing to evaluate how sensitive bacterial isolates are to amoxicillin-clavulanate. They help laboratories determine whether bacteria are susceptible, intermediate, or resistant to this antibiotic combination, guiding appropriate treatment decisions.

• How are the Augmentin 30 mcg Sensitivity Discs supplied and intended for use?

  The discs are supplied sterile and intended for single-use in vitro testing. Each disc is meant to be used once in a controlled laboratory setting to perform antimicrobial susceptibility tests on bacterial cultures, ensuring accurate and reliable results.

• Are these discs reusable, or are they meant for one-time use?

  These discs are explicitly designed for single-use only. Reusing them could compromise sterility and accuracy, leading to unreliable test results. Always follow the manufacturer’s instructions for proper handling and disposal.

• What regulatory classification and clearance do these discs hold?

  The Augmentin 30 mcg Sensitivity Discs fall under 21 CFR 866.1620 and have received FDA 510(k) clearance (K843172) as substantially equivalent to a predicate device. They are classified under the microbiology advisory committee and adhere to standard laboratory practices for antimicrobial susceptibility testing.

• How should these discs be stored to maintain their integrity?

  While the provided data does not specify storage conditions, antimicrobial susceptibility test discs like these are typically stored in a cool, dry place, protected from light and contamination. Always refer to the manufacturer’s instructions for precise storage guidelines to ensure optimal performance and sterility.