Home / 510(k) Clearances / K891096

510(k) K891096

VIS-DISK HCG (EIA) JPL-041M by Leeco Diagnostics, Inc. — Product Code DHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1989
Date Received
March 2, 1989
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 Leeco Diagnostics, Inc.

  • K895765 — LEECO PREVIEW(R) EBV (EIA) (October 31, 1989)
  • K894122 — LEECO VIS-DISK STREP-A (EIA) (August 15, 1989)
  • K891095 — VIS-DISK HCG (EIA) LYOPHILIZED JPL-044M (June 16, 1989)
  • K883269 — PRL-QUANT (September 13, 1988)
  • K880577 — CONCEP-7-BHCG (March 15, 1988)
  • K880069 — LEECO PREGNASTICK (EIA) CATALOG #003 (February 11, 1988)
  • K870259 — VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044 (March 10, 1987)
  • K864170 — LEECO VIS-CUBE STREP A (EIA) (February 3, 1987)
  • K863999 — VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042 (January 9, 1987)
  • K863933 — VIS-CUBE HCG (EIA) (December 15, 1986)

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)