Ace Clinical Chemistry System

• • Terminated Z-0676-06 FDA Unclassified (pre-2012) ·initiated 26 Jan 2006

  Inaccurate test results. The magnesium values for the A31/A41 Gemcal Serum calibrator gave control results that were biased approx. 20% high.

510(k) Number

K930104 ↗

FDA Product Code

JIX

Device Class

Class II

Regulation

21 CFR Part 862.1150

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• Ace Hdl-C Reagent

  Class I

  FDA 510(k) K971526 Active Cleared 21 May 1997

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  FDA 510(k) K941489 Active Cleared 18 Jul 1994

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  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. →