Additional Allergens for Ige Fast-Plus Test

No FDA recalls on record, checked 9 Oct 2026.

510(k) Number

K880003 ↗

FDA Product Code

DHB

Device Class

Class II

Regulation

21 CFR Part 866.5750

Advisory Committee

Immunology

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

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