I-Stat Ionized Calcium Test

• • Terminated Z-1540-2009 FDA Unclassified (pre-2012) ·initiated 23 Feb 2009 ·via K934642, on the same 510(k)

  Equipment problem: i-STAT cartridges were not properly sealed as the packaging system jammed, causing compromised seals.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K934642 ↗

FDA Product Code

JFP

Device Class

Class II

Regulation

21 CFR Part 862.1145

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Modification to: I-Stat Portable Clinical Analyzer

  Class II

  FDA 510(k) K012478 Active Cleared 20 Aug 2001

• Model 100 Portable Clinical Analyzer and Test Pack

  Class II

  FDA 510(k) K894914 Active Cleared 16 Oct 1989

• I-Stat Control Levels 1, 2, 3

  Class I

  FDA 510(k) K934641 Active Cleared 9 Dec 1993

• I-Stat Tests for Acid-Base Parameters

  Class II

  FDA 510(k) K936081 Active Cleared 24 Feb 1994

• I-Stat B-Type Natriuretic Peptide (Bnp)

  Class II

  FDA 510(k) K053597 Active Cleared 21 Jul 2006

• I-Stat 200 Portable Clinical Analyzer Open recall

  Class II

  FDA 510(k) K940918 Active Cleared 10 May 1994

See all devices from I-Stat Corp. →