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510(k) K801843

T3(125) RADIOIMMUNOASSAY KIT by Technia Diagnostics , Ltd. — Product Code CDP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1980
Date Received
August 1, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Total Triiodothyronine
Device Class
Class II
Regulation Number
862.1710
Review Panel
CH
Submission Type

Other clearances by Technia Diagnostics , Ltd.

  • K861978 — AUTOFLUOR V (June 10, 1986)
  • K801202 — DIGOXIN RADIOIMMUNOASSAY KIT (June 20, 1980)
  • K801203 — CORTISOL RADIOIMMUNOASSAY KIT (June 9, 1980)
  • K791361 — T3 UPTAKE RADIOIMMUNOASSAY KIT (August 16, 1979)
  • K790919 — HPL RIA KIT (June 28, 1979)
  • K790495 — THYROXINE RIA KIT (May 3, 1979)
  • K782024 — RIA KIT, VITAMIN B12 (February 28, 1979)
  • K782025 — GENTAMICIN FLUROIMMUNASSAY KIT (January 26, 1979)

Other clearances for product code CDP

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  • K991311 — TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005 (June 2, 1999)
  • K991252 — AIA-PACK FT3 ASSAY (May 11, 1999)
  • K981824 — OPTICOAT T3 EIA KIT (December 22, 1998)
  • K983439 — ABBOTT ARCHITECT FREE T3 (November 20, 1998)
  • K983434 — ABBOTT ARCHITECT TOTAL T3 (November 20, 1998)
  • K974027 — AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK (February 2, 1998)
  • K974634 — IMMULITE FREE T3 (January 2, 1998)
  • K973966 — ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (October 31, 1997)