Home / 510(k) Clearances / K911796

510(k) K911796

IMMULITE(TM) HCG by Cirrus Diagnostics, Inc. — Product Code DHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1991
Date Received
April 22, 1991
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 Cirrus Diagnostics, Inc.

  • K921704 — IMMULITE(R) FSH (June 9, 1992)
  • K920411 — IMMULITE HLH (March 11, 1992)
  • K914833 — IMMULITE DIGOXIN (November 22, 1991)
  • K910677 — IMMULITE(TM) T-UPTAKE (April 29, 1991)
  • K910261 — IMMULITE(TM) TOTAL T4 (April 16, 1991)
  • K905648 — CRP LIPID REAGENT TEST PACK (March 6, 1991)
  • K905214 — IMMULITE (TM) TOTAL T3 (February 1, 1991)
  • K905769 — IMMULITE HS-TSH (January 31, 1991)
  • K905215 — IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER (January 11, 1991)

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)