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510(k) K905532

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

K905532 is an FDA 510(k) premarket notification submitted by Ciba Corning Diagnostics Corp. for the device "CIBA CORNING ACS T4 IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on Jan 15, 1991. The device falls under product code CDX (Radioimmunoassay, Total Thyroxine), a Class II device regulated under 21 CFR 862.1700. Ciba Corning Diagnostics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 15, 1991
Date Received
Dec 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.

  • K962559 — ACS CORTISOL IMMUNOASSAY (Nov 5, 1996)
  • K963251 — CIBA CORNING ACS;180 DPD ASSAY (Oct 15, 1996)
  • K961807 — CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4 (Jul 26, 1996)
  • K961657 — CIBA CORNING 400 SYSTEM (Jun 25, 1996)
  • K962021 — CIBA CORNING 348 SYSTEM (Jun 24, 1996)
  • K962126 — ACS CKMB II IMMUNOASSAY (Jun 21, 1996)
  • K962041 — ACS LH2 IMMUNOASSAY (Jun 21, 1996)
  • K961510 — ACS FRT4 IMMUNOASSAY (Jun 17, 1996)
  • K960246 — LIQUID CARDIAC MARKER 1,2,3 ASSAYED (Apr 23, 1996)
  • K955873 — ACS PHENYTOIN ASSAY (Mar 11, 1996)

Other clearances for product code CDX

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

FDA data resources