Home / 510(k) Clearances / K895396

510(k) K895396

CYBERFLUOR FIAGEN TSH by Cyberfluor, Inc. — Product Code JLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1989
Date Received
September 1, 1989
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 Cyberfluor, Inc.

  • K923410 — FIAGEN PROGESTERONE (December 3, 1992)
  • K905656 — FLAGEN TRIIODOTHYRONINE (T3) ASSAY (January 23, 1991)
  • K904539 — FLAGEN TM FREE T4 (November 30, 1990)
  • K900621 — FIAGEN(TM) HLH.S (March 1, 1990)
  • K895186 — FIAGEN T3 UPTAKE CATALOGUE #101-402 (November 8, 1989)
  • K884708 — FIAGEN HFSH TIME-RESOLVED FLUOROIMMUNOASSAY KIT (January 17, 1989)
  • K884707 — FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KIT (January 17, 1989)
  • K884201 — FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT (December 14, 1988)
  • K883182 — FIAGEN RUBELLA IGG (October 31, 1988)
  • K882823 — FIAGEN HGH FLUOROIMMUNOASSAY KIT (August 30, 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)