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510(k) K042676

NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY by Nichols Institute Diagnostics — Product Code DHA

K042676 is an FDA 510(k) premarket notification submitted by Nichols Institute Diagnostics for the device "NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY". The FDA issued a decision of Substantially Equivalent on December 17, 2004. The device falls under product code DHA (System, Test, Human Chorionic Gonadotropin), a Class II device regulated under 21 CFR 862.1155. Nichols Institute Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2004
Date Received
September 29, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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 Nichols Institute Diagnostics

  • K050784 — NICHOLS ADVANTAGE ALDOSTERONE ASSAY (June 1, 2005)
  • K042689 — NICHOLS ADVANTAGE CORTISOL (December 9, 2004)
  • K040813 — NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022 (June 8, 2004)
  • K033727 — NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY (April 22, 2004)
  • K033302 — NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040 (January 26, 2004)
  • K032188 — NICHOLS ADVANTAGE ALDOSTERONE ASSAY (July 31, 2003)
  • K022356 — NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASS (October 25, 2002)
  • K022472 — PARATHYROID HORMONE TEST SYSTEM/NICHOLS ADVANTAGE QUICK-INTRAOPERATIVE BIO-INTAC (October 9, 2002)
  • K013992 — NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84) IMMUNO (December 13, 2001)
  • K012367 — VITAMIN D TEST SYSTEM NICHOLS ADVANTAGE 25-HYDROXYVITAMIN D (October 9, 2001)

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)

FDA data resources