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510(k) K974027

AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK by Alfa Biotech (Uk) , Ltd. — Product Code CDP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1998
Date Received
October 23, 1997
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 Alfa Biotech (Uk) , Ltd.

  • K980574 — AURAFLEX TSH-3 200 TEST PACK MODEL NUMBER 80600, AURAFLEX TSH-3 CALIBRATOR PACK (March 24, 1998)
  • K974505 — AURAFLEX FERRITIN 200 TEST PACK 80500, AURAFLEX FERRITIN CALIBRATOR PACK 80501 (February 17, 1998)

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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)
  • K974634 — IMMULITE FREE T3 (January 2, 1998)
  • K973966 — ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (October 31, 1997)
  • K971779 — TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA (June 16, 1997)