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510(k) K952751

BIOCIRCUITS IOS T4/TU TEST CARTRIDGES by Biocircuits Corp. — Product Code KLI

K952751 is an FDA 510(k) premarket notification submitted by Biocircuits Corp. for the device "BIOCIRCUITS IOS T4/TU TEST CARTRIDGES". The FDA issued a decision of Substantially Equivalent on November 20, 1995. The device falls under product code KLI (Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine), a Class II device regulated under 21 CFR 862.1700. Biocircuits Corp. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 1995
Date Received
June 15, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Device Class
Class II
Regulation Number
862.1700
Review Panel
CH
Submission Type

Other clearances by Biocircuits Corp.

  • K981634 — BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS (October 13, 1998)
  • K980819 — BIOCIRCUITS IOS FREE THYROXINE (FT4) TEST CARTRIDGES BIOCIRCUITS IOS CONTROLS (April 3, 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)

Other clearances for product code KLI

  • K160495 — VITROS® Automation Solutions (October 18, 2016)
  • K131515 — ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT (August 14, 2013)
  • K103484 — GSP NEONATAL THYROXINE (T4) (April 22, 2011)
  • K082638 — ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL (February 26, 2009)
  • K030860 — ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300 (August 22, 2003)
  • K023369 — ACCESS TOTAL T4 ASSAY (December 9, 2002)
  • K001603 — REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105) (October 5, 2000)
  • K000600 — SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS (March 27, 2000)
  • K991432 — BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007 (June 2, 1999)
  • K982298 — OPTICOAT T4 EIA KIT (February 3, 1999)

FDA data resources