Biosphere Anaerobic Environmental Device

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K862123 ↗

FDA Product Code

KZJ

Device Class

Class I

Regulation

21 CFR Part 866.2580

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Chamber, Aerobic

  Class I

  FDA 510(k) K780440 Active Cleared 10 Apr 1978

• Dropper, Cepti-Seal Lavtophenol

  Class I

  FDA 510(k) K781868 Active Cleared 22 Nov 1978

• Dropper, Solution Trichrome, Cepti-Seal

  Class I

  FDA 510(k) K781062 Active Cleared 14 Aug 1978

• Toxi-Lab Cannabinoid Thc Screen

  Class II

  FDA 510(k) K831456 Active Cleared 30 Jun 1983

• Envinet(Tm)

  Unclassified

  FDA 510(k) K874551 Active Cleared 22 Jan 1988

• Bac-T-Screen Bacteriuria Detection Dev

  Class I

  FDA 510(k) K823850 Active Cleared 1 Mar 1983

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