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510(k) K791232

DAC-CEL T3 by Burroughs Wellcome Co. — Product Code CDP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 1979
Date Received
July 2, 1979
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 Burroughs Wellcome Co.

  • K820069 — WELLCOGEN GROUP B (February 18, 1982)
  • K813508 — SAC-CEL (December 29, 1981)
  • K810215 — DAC-CEL HCG (April 17, 1981)
  • K810214 — DAC-CEL DIAGNATAL (March 6, 1981)
  • K810212 — DAC-CEL T3 UPTAKE (February 10, 1981)
  • K810213 — DAC-CEL TSH (February 10, 1981)
  • K791231 — DAC-CEL T4 (September 4, 1979)
  • K781607 — STREP-TEX (October 17, 1978)
  • K780873 — THYMUNE-M (June 14, 1978)
  • K780874 — THYMUNE-T (June 14, 1978)

Other clearances for product code CDP

  • K001607 — REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104) (October 5, 2000)
  • K991692 — CHIRON DIAGNOSTICS ACS: 180 FT3 (June 18, 1999)
  • 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)