Api Uniscept Kb

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K895796 ↗

FDA Product Code

JWY

Device Class

Class II

Regulation

21 CFR Part 866.1640

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Api 50 E

  Class I

  FDA 510(k) K770989 Active Cleared 29 Jun 1977

• Aso Sure Plus

  Class I

  FDA 510(k) K820786 Active Cleared 8 Apr 1982

• Api 20GP

  Class I

  FDA 510(k) K830525 Active Cleared 18 May 1983

• Aladin (TM)

  Class II

  FDA 510(k) K865062 Active Cleared 25 Mar 1987

• Artap Arterial Blood Sampling Device

  Class I

  FDA 510(k) K843360 Active Cleared 31 Oct 1984

• Referee Bft Blood for Tonometry

  Class I

  FDA 510(k) K792447 Active Cleared 27 Dec 1979

See all devices from Analytical Products, Inc. →

• What is the API UNISCEPT KB used for?

  The API UNISCEPT KB is used for determining the susceptibility of microorganisms to antimicrobial agents through manual testing methods in microbiology laboratory settings, as defined by its device type and nomenclature.

• Is the API UNISCEPT KB sterile or non-sterile, and is it intended for single use or reuse?

  The API UNISCEPT KB is supplied as a non-sterile system and is intended for reuse, meaning it can be cleaned and used multiple times in accordance with laboratory protocols for manual antimicrobial susceptibility testing.

• What regulatory pathway was used for the API UNISCEPT KB, and what is its product code?

  The API UNISCEPT KB received FDA 510(k) clearance under product code JWY, indicating it was found substantially equivalent to a legally marketed predicate device for manual antimicrobial susceptibility test systems.