Home / 510(k) Clearances / K920442

510(k) K920442

IMMUCHEM TSH-MW ELISA by Icn Biomedicals, Inc. — Product Code JLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1992
Date Received
February 3, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Thyroid-Stimulating Hormone
Device Class
Class II
Regulation Number
862.1690
Review Panel
CH
Submission Type

Other clearances by Icn Biomedicals, Inc.

  • K030211 — RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016 (June 13, 2003)
  • K023252 — RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020 (November 22, 2002)
  • K926106 — IMMUCHEM PHE-MW EA (February 8, 1995)
  • K922944 — IMMUCHEM LH-MW ELISA (February 2, 1993)
  • K922376 — ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT (October 5, 1992)
  • K922715 — IMMUCHEM PRL-MW ELISA (October 5, 1992)
  • K913963 — IMMUCHEM NEONATAL TSH-MP ELISA (December 13, 1991)
  • K902445 — LYMPHO SEP(TM) (August 22, 1990)
  • K885198 — 17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIA (February 23, 1989)
  • K881005 — IMMUCHEM HUMAN CHORIONIC GONADOTROPIN HORMONE HCG (May 27, 1988)

Other clearances for product code JLW

  • K251543 — Atellica® IM TSH3-Ultra II (TSH3ULII) (February 6, 2026)
  • K243570 — Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimens (April 25, 2025)
  • K234091 — Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0 (July 22, 2024)
  • K233050 — ADVIA Centaur® TSH3-Ultra II (TSH3ULII) (April 4, 2024)
  • K222116 — Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL (July 13, 2023)
  • K221225 — Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer (November 10, 2022)
  • K190773 — Elecsys TSH (April 16, 2019)
  • K170232 — AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer (October 13, 2017)
  • K171103 — Lumipulse G TSH-III Immunoreaction Cartridges (July 28, 2017)
  • K162698 — MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer (July 14, 2017)