Enterotube II

No FDA recalls found in the data synced 9 Oct 2026.

510(k) Number

K781236 ↗

FDA Product Code

JSS

Device Class

Class I

Regulation

21 CFR Part 866.2660

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Cobas Reagent for Calcium

  Class II

  FDA 510(k) K823577 Active Cleared 7 Jan 1983

• Test, in-Vitro Diagnostic

  Not classified

  FDA 510(k) K760089 Active Cleared 20 Jul 1976

• Hcg Radioimmunoassay

  Class II

  FDA 510(k) K811116 Active Cleared 13 May 1981

• Cobas Creatinine Standards

  Class II

  FDA 510(k) K823572 Active Cleared 7 Jan 1983

• Sensi-Tex

  Class II

  FDA 510(k) K790267 Active Cleared 21 Mar 1979

• Abuscreen Radioimmunoassay - Amphetamine

  Class II

  FDA 510(k) K823212 Active Cleared 29 Nov 1982

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