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510(k) K897001

TOSOH AIA-PACK T3 by Tosoh Corp. — Product Code CDP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1990
Date Received
December 18, 1989
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 Tosoh Corp.

  • K023239 — AIA-PACK CA 19-9 (December 23, 2002)
  • K023240 — ST AIA-PACK CA 19-9 (December 23, 2002)
  • K923021 — AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM (July 21, 1992)
  • K913663 — AIA-PACK T-U (September 30, 1991)
  • K913298 — AIA-PACK CK-MB (September 27, 1991)
  • K913493 — AIA-PACK FT4 (September 10, 1991)
  • K903628 — AIA-PACK IRI (September 7, 1990)
  • K901965 — MPR-4A - MICRO-PLATE READER (May 10, 1990)
  • K901674 — AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM (May 2, 1990)
  • K896982 — AIA-PACK T4 (March 9, 1990)

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)