Engstrom Erica

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K812642 ↗

FDA Product Code

CBK

Device Class

Class II

Regulation

21 CFR Part 868.5895

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Ultrospec W/Apple II -4050-

  Class I

  FDA 510(k) K834489 Active Cleared 10 Feb 1984

• Ultrospec K Kinetics Spectrophotometer

  Class I

  FDA 510(k) K861194 Active Cleared 24 Apr 1986

• Engstom Edith

  Class I

  FDA 510(k) K821365 Active Cleared 29 Jun 1982

• Delfia(Tm) Thyroxine (T4) Kit

  Class II

  FDA 510(k) K871303 Active Cleared 17 Jun 1987

• Engstrom Metabolic Computer

  Class II

  FDA 510(k) K821344 Active Cleared 28 May 1982

• Delfia(Tm) Ferritin Kit

  Class II

  FDA 510(k) K872955 Active Cleared 21 Aug 1987

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