Ace T Uptake Reagent Tu Calibrators

No FDA recalls found in the data synced 10 Oct 2026.

510(k) Number

K981375 ↗

FDA Product Code

KHQ

Device Class

Class II

Regulation

21 CFR Part 862.1715

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Ace Primidone Reagent, Aed Calibrators

  Class II

  FDA 510(k) K973582 Active Cleared 12 Nov 1997

• Triglycerides Reagent

  Class I

  FDA 510(k) K954187 Active Cleared 23 Oct 1995

• Ace Hdl-C Reagent

  Class I

  FDA 510(k) K971526 Active Cleared 21 May 1997

• Ace Clinical Chemistry System

  Class II

  FDA 510(k) K941489 Active Cleared 18 Jul 1994

• Ace Iron Reagent

  Class I

  FDA 510(k) K944911 Active Cleared 10 Feb 1995

• Ace Ldl-C Reagent, Ldl-C Calibrator, Ldl-C Controls

  Class I

  FDA 510(k) K991733 Active Cleared 13 Jul 1999

See all devices from Schiapparelli Biosystems, Inc. →