Home / 510(k) Clearances / K840088

510(k) K840088

BIODEX ACT-O-KIT TSH-RIA- by Biodan Medical Systems, Ltd. — Product Code JLW

K840088 is an FDA 510(k) premarket notification submitted by Biodan Medical Systems, Ltd. for the device "BIODEX ACT-O-KIT TSH-RIA-". The FDA issued a decision of Substantially Equivalent on May 7, 1984. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Biodan Medical Systems, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 1984
Date Received
January 10, 1984
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 Biodan Medical Systems, Ltd.

  • K932153 — THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROME (September 7, 1993)
  • K930261 — RTM REHABILITATION TREADMILL, MODEL #945-200 (May 26, 1993)
  • K930262 — TREATMENT TABLE, MODEL #825-100 (March 29, 1993)
  • K930259 — TRACTION TABLE MODEL #825-200 (March 24, 1993)
  • K926083 — NUCLEAR PATIENT SANNING TABLES, VARIOUS TYPES (February 12, 1993)
  • K926082 — CARDIAC STRESS TABLE, 056-180/UNIV ROLL STRESS ATT (December 30, 1992)
  • K922591 — UROLOGICAL C-ARM TABLE, MODEL #056-450 (November 27, 1992)
  • K922604 — DELUXE ADJUSTABLE HEIGHT ULTRASOUND TABLE (October 20, 1992)
  • K922605 — TRENDELENBURG ULTRASOUND TABLE, MODEL # 056-603 (October 20, 1992)
  • K923350 — CLOSED CHAIN ATTACHMENT, MODEL #820-520 (July 23, 1992)

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