Giardia Guard

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

510(k) Number

K842052 ↗

FDA Product Code

LIB

Device Class

Class I

Regulation

21 CFR Part 866.2660

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Gleman Acd-2020 Automatic Computing Densitometer

  Class I

  FDA 510(k) K850260 Active Cleared 27 Feb 1985

• Drug Standard Set

  Class II

  FDA 510(k) K884177 Active Cleared 17 Feb 1989

• Pharmassure Large Volume Transfer Filters

  Class II

  FDA 510(k) K943127 Active Cleared 29 Sep 1994

• Electrophoresis Reagent Set, Hdl

  Class I

  FDA 510(k) K790791 Active Cleared 15 Jun 1979

• Hi-Phore High Resolution Electrophores

  Class I

  FDA 510(k) K821303 Active Cleared 12 May 1982

• Autophor 128

  Class II

  FDA 510(k) K810047 Active Cleared 5 Feb 1981

See all devices from Gelman Sciences, Inc. →