I-Stat Control Levels 1, 2, 3

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K934641 ↗

FDA Product Code

JJR

Device Class

Class I

Regulation

21 CFR Part 862.1660

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 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

• I-Stat Cardiac Markers Control Level 1, 2, and 3; Cardiac Markers Calibration Verification Control Set

  Class I

  FDA 510(k) K031873 Active Cleared 7 Oct 2003

See all devices from I-Stat Corp. →