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510(k) K811213

T3 (RIA) KIT by Immuno Assay Corp. — Product Code CDP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 1981
Date Received
May 4, 1981
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 Immuno Assay Corp.

  • K833842 — RIA COAT DIGOXIN (January 17, 1984)
  • K833745 — RIACOAT T-4 (January 4, 1984)
  • K820089 — TSH (RIA) KIT (January 28, 1982)
  • K820074 — CORTISOL (RIA) KIT (January 28, 1982)
  • K811954 — COMBO-FER IRON DIAGNOSTIC (July 27, 1981)
  • K811725 — TBG DIAGNOSTIC KIT (July 10, 1981)
  • K811212 — DIGOXIN (RIA) KIT (May 21, 1981)
  • K810857 — T3 UPTAKE KIT (April 8, 1981)
  • K810811 — T4 RIA KIT (April 7, 1981)

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)