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510(k) K930050

SIA THYROID STIMULATING HORMONE ELISA KIT by Sigma Chemical Co. — Product Code JLW

K930050 is an FDA 510(k) premarket notification submitted by Sigma Chemical Co. for the device "SIA THYROID STIMULATING HORMONE ELISA KIT". The FDA issued a decision of Substantially Equivalent on August 19, 1993. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Sigma Chemical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 1993
Date Received
January 5, 1993
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 Sigma Chemical Co.

  • K933694 — SIGMA GLUCOSE REAGENT (November 4, 1994)
  • K933678 — SIGMA CALCIUM REAGENT (March 11, 1994)
  • K933696 — SIGMA ELECTROLYTE REFERENCE REAGENT (January 3, 1994)
  • K933691 — SIGMA CO2 ALKALINE BUFFER REAGENT (December 17, 1993)
  • K933679 — SIGMA BUN REAGENT (December 17, 1993)
  • K933703 — SIGMA WASH CONCENTRATE SOLUTION (December 10, 1993)
  • K933692 — SIGMA CO2 ACID REAGENT (December 9, 1993)
  • K933695 — SIGMA ELECTROLYTE BUFFER (October 22, 1993)
  • K933697 — SIGMA CRE REAGENT (October 18, 1993)
  • K933693 — SIGMA CX-3 CALIBRATION STANDARD LEVEL 2 (October 13, 1993)

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)

FDA data resources