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510(k) K905532

CIBA CORNING ACS T4 IMMUNOASSAY by Ciba Corning Diagnostics Corp. — Product Code CDX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 1991
Date Received
December 10, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Total Thyroxine
Device Class
Class II
Regulation Number
862.1700
Review Panel
CH
Submission Type

Other clearances by Ciba Corning Diagnostics Corp.

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  • K963251 — CIBA CORNING ACS;180 DPD ASSAY (October 15, 1996)
  • K961807 — CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4 (July 26, 1996)
  • K961657 — CIBA CORNING 400 SYSTEM (June 25, 1996)
  • K962021 — CIBA CORNING 348 SYSTEM (June 24, 1996)
  • K962126 — ACS CKMB II IMMUNOASSAY (June 21, 1996)
  • K962041 — ACS LH2 IMMUNOASSAY (June 21, 1996)
  • K961510 — ACS FRT4 IMMUNOASSAY (June 17, 1996)
  • K960246 — LIQUID CARDIAC MARKER 1,2,3 ASSAYED (April 23, 1996)
  • K955873 — ACS PHENYTOIN ASSAY (March 11, 1996)

Other clearances for product code CDX

  • K961490 — ELECSYS T4 ASSAY (June 13, 1996)
  • K954312 — ACTIVE THYROXINE RIA (October 7, 1995)
  • K943416 — DELFIA NEONATAL THYROXINE KIT (March 10, 1995)
  • K934384 — AXSYM(TM) TOTAL T4 (June 21, 1994)
  • K932980 — TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116 (October 18, 1993)
  • K933426 — STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO (August 26, 1993)
  • K931295 — IQ TT4 ASSAY (July 20, 1993)
  • K926563 — AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KIT (March 18, 1993)
  • K925110 — ABBOTT IMX T4 (January 26, 1993)
  • K925109 — ABBOTT TDX/TDXFLX TT4 (January 4, 1993)