Biocircuits Ios Prostate Specific Antigen (Psa) Test Cartridges, Biocircuits Ios Psa Controls

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K981634 ↗

FDA Product Code

LTJ

Device Class

Class II

Regulation

21 CFR Part 866.6010

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Biocircuits Ios (in-Office System)

  Class I

  FDA 510(k) K952719 Active Cleared 22 Nov 1995

• Biocircuits Ios Tsh Test Cartridges/Thyroid Controls

  Class II

  FDA 510(k) K961566 Active Cleared 18 Nov 1996

• Biocircuits Ios Quantitative Hcg Test Cartridges/Biocircuits Ios Immunoassay Controls

  Class I

  FDA 510(k) K963770 Active Cleared 5 Dec 1996

• Biocircuits Ios T4/Tu Test Cartridges

  Class II

  FDA 510(k) K952751 Active Cleared 20 Nov 1995

• Biocircuits Ios T4 Test Cartridge

  Class II

  FDA 510(k) K953837 Active Cleared 20 Nov 1995

• Biocircuits Ios Serum Pregnancy Test Cartridges/Immunoassay Controls

  Class II

  FDA 510(k) K961792 Active Cleared 21 Aug 1996

See all devices from Biocircuits Corp. →