American Histo-Id Sys Primary Kit Psa Prostate Ant

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

510(k) Number

K855034 ↗

FDA Product Code

LIJ

Device Class

Class I

Regulation

21 CFR Part 864.4400

Advisory Committee

Pathology

FDA Decision

SESE Substantially Equivalent

• Hep-2 Cells

  Class I

  FDA 510(k) K842834 Active Cleared 28 Aug 1984

• Human Fibroblastic Cells-Human Newborn

  Class I

  FDA 510(k) K834117 Active Cleared 22 Mar 1984

• Cylomegalovirus Direct Fluorescent Anti

  Class II

  FDA 510(k) K820895 Active Cleared 3 May 1982

• Cytomegalovirus Direct Fluorescent Antibody Kit

  Class II

  FDA 510(k) K860279 Active Cleared 13 May 1986

• Chlamydiae Isolation Medium W/Cyclohex

  Class I

  FDA 510(k) K834122 Active Cleared 13 Feb 1984

• Pbs W/MG+2 & CA+2

  Class I

  FDA 510(k) K834136 Active Cleared 22 Mar 1984

See all devices from Bartels Immunodiagnostic Supplies, Inc. →