Easy-Test Chem Cal Levels 1, 2&3/Items 67617 Abc/95

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K871638 ↗

FDA Product Code

JIX

Device Class

Class II

Regulation

21 CFR Part 862.1150

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Alanine Aminotransferase Test

  Class I

  FDA 510(k) K903198 Active Cleared 12 Sep 1990

• Emds Tm Phenobarbital(Phno) Testpack, #67677/95

  Class II

  FDA 510(k) K864926 Active Cleared 7 Jan 1987

• Olympus(Tm) Total Bilirubin

  Class II

  FDA 510(k) K897174 Active Cleared 10 May 1990

• Systamate Aspartate Aminotransferase Test Technico

  Class II

  FDA 510(k) K922857 Active Cleared 9 Sep 1992

• Systemate (Tm) Alanine Transferase (Alt)

  Class II

  FDA 510(k) K863094 Active Cleared 29 Aug 1986

• Systemate Ldh, 67210

  Class II

  FDA 510(k) K843269 Active Cleared 13 Sep 1984

See all devices from Em Diagnostic Systems, Inc. →

• What is the EASY-TEST CHEM CAL LEVELS 1,2&3/ITEMS 67617 ABC/95 used for?

  This device is a multi-analyte mixture calibrator used for calibration in clinical chemistry testing procedures, as specified in its device name and intended use description.

• How is the EASY-TEST CHEM CAL LEVELS 1,2&3/ITEMS 67617 ABC/95 supplied and what is its classification?

  It is supplied as a multi-analyte mixture calibrator and is classified as a Class II medical device under product code JIX, based on its regulatory submission and device classification data.

• What regulatory pathway was used for the EASY-TEST CHEM CAL LEVELS 1,2&3/ITEMS 67617 ABC/95?

  The device received FDA 510(k) clearance under submission number K871638, indicating it was found substantially equivalent to a legally marketed predicate device through the traditional 510(k) pathway.