Lbi-100 37DEGREES Incubator

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

510(k) Number

K830405 ↗

FDA Product Code

JTQ

Device Class

Class I

Regulation

21 CFR Part 866.2540

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Legionella Ifa Kit I

  Class II

  FDA 510(k) K831760 Active Cleared 8 Aug 1983

• Automated Elisa Reader Lbi 300

  Class I

  FDA 510(k) K830227 Active Cleared 10 Mar 1983

• Amebiasis Bio-Enzabead Screen Kit

  Class II

  FDA 510(k) K831133 Active Cleared 8 Jun 1983

• Toxo Ipa Kit Ian Indirect Fluorescent

  Class II

  FDA 510(k) K832069 Active Cleared 26 Sep 1983

• Legionella Dfa Kit I

  Class II

  FDA 510(k) K830820 Active Cleared 8 Jun 1983

• Vzv Bio-Enzabead Screen Kit

  Class II

  FDA 510(k) K833637 Active Cleared 10 Feb 1984

See all devices from Bionetic Laboratory Products →