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510(k) K991692

CHIRON DIAGNOSTICS ACS: 180 FT3 by Chiron Diagnostics Corp. — Product Code CDP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 1999
Date Received
May 18, 1999
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 Chiron Diagnostics Corp.

  • K992157 — CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY (August 5, 1999)
  • K991582 — CHIRON DIAGNOSTICS ACS: 180 FOLATE (June 30, 1999)
  • K982680 — CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY (October 15, 1998)
  • K981839 — ACS:CENTAUR PSA2 IMMUNOASSAY (August 12, 1998)
  • K981478 — ACS:CENTAUR CEA (August 12, 1998)
  • K981592 — ACS:CENTAUR AFP (July 7, 1998)
  • K980528 — CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI) (March 3, 1998)
  • K974029 — ACS TOBRAMYCIN (February 12, 1998)
  • K974325 — CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN (December 8, 1997)
  • K970695 — ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER AN (August 8, 1997)

Other clearances for product code CDP

  • K001607 — REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104) (October 5, 2000)
  • 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)
  • K983434 — ABBOTT ARCHITECT TOTAL T3 (November 20, 1998)
  • K983439 — ABBOTT ARCHITECT FREE 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)
  • K971779 — TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA (June 16, 1997)