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510(k) K980819

BIOCIRCUITS IOS FREE THYROXINE (FT4) TEST CARTRIDGES BIOCIRCUITS IOS CONTROLS by Biocircuits Corp. — Product Code CEC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 1998
Date Received
March 3, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Free Thyroxine
Device Class
Class II
Regulation Number
862.1695
Review Panel
CH
Submission Type

Other clearances by Biocircuits Corp.

  • K981634 — BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS (October 13, 1998)
  • K963770 — BIOCIRCUITS IOS QUANTITATIVE HCG TEST CARTRIDGES/BIOCIRCUITS IOS IMMUNOASSAY CON (December 5, 1996)
  • K961566 — BIOCIRCUITS IOS TSH TEST CARTRIDGES/THYROID CONTROLS (November 18, 1996)
  • K961792 — BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS (August 21, 1996)
  • K952719 — BIOCIRCUITS IOS (IN-OFFICE SYSTEM) (November 22, 1995)
  • K953837 — BIOCIRCUITS IOS T4 TEST CARTRIDGE (November 20, 1995)
  • K952751 — BIOCIRCUITS IOS T4/TU TEST CARTRIDGES (November 20, 1995)

Other clearances for product code CEC

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  • K220456 — Elecsys FT4 IV (April 7, 2023)
  • K182423 — MAGLUMI 2000 FT4 (October 4, 2018)
  • K181233 — Elecsys FT4 III (September 18, 2018)
  • K173122 — Abbott Architect Free T4 (October 27, 2017)
  • K152422 — FREND™ Free T4 Test System (February 17, 2016)
  • K132058 — VIDAS FT4 (June 8, 2015)
  • K140859 — DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYR (November 26, 2014)
  • K140842 — DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYRO (November 26, 2014)
  • K131244 — ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET (January 27, 2014)