Home / 510(k) Clearances / K961792

510(k) K961792

BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS by Biocircuits Corp. — Product Code DHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1996
Date Received
May 9, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Human Chorionic Gonadotropin
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

Other clearances by Biocircuits Corp.

  • K981634 — BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS (October 13, 1998)
  • K980819 — BIOCIRCUITS IOS FREE THYROXINE (FT4) TEST CARTRIDGES BIOCIRCUITS IOS CONTROLS (April 3, 1998)
  • K963770 — BIOCIRCUITS IOS QUANTITATIVE HCG TEST CARTRIDGES/BIOCIRCUITS IOS IMMUNOASSAY CON (December 5, 1996)
  • K961566 — BIOCIRCUITS IOS TSH TEST CARTRIDGES/THYROID CONTROLS (November 18, 1996)
  • K952719 — BIOCIRCUITS IOS (IN-OFFICE SYSTEM) (November 22, 1995)
  • K952751 — BIOCIRCUITS IOS T4/TU TEST CARTRIDGES (November 20, 1995)
  • K953837 — BIOCIRCUITS IOS T4 TEST CARTRIDGE (November 20, 1995)

Other clearances for product code DHA

  • K233581 — VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack (May 8, 2024)
  • K223690 — iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) (December 11, 2023)
  • K230937 — Alinity i Total ß-hCG Reagent Kit, GLP systems Track (June 5, 2023)
  • K230790 — Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT (May 19, 2023)
  • K221990 — Access Total ßhCG (5th IS) (December 27, 2022)
  • K212221 — Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemilu (December 13, 2021)
  • K203227 — Elecsys HCG STAT (August 18, 2021)
  • K200210 — ADVIA Centaur® Total hCG assay (July 13, 2021)
  • K192547 — MAGLUMI 2000 HCG/ß-HCG (January 17, 2020)
  • K192790 — Atellica IM Total hCG (ThCG) (October 30, 2019)