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510(k) K931295

IQ TT4 ASSAY by Becton Dickinson Advanced Diagnostics — Product Code CDX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1993
Date Received
March 15, 1993
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 Becton Dickinson Advanced Diagnostics

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  • K926356 — PRECISE(TM) HCG(URINE/SERUM) AND PRCISE(TM) PREG (March 18, 1993)
  • K925132 — BECTON DICKINSON THYROID STIMULATING HORMONE SYSTE (December 28, 1992)
  • K923673 — PRECISE STREP A (September 28, 1992)
  • K923060 — IQ IMMUNOCHEMISTRY SISTEM; IQ TSH ASSAY (September 15, 1992)
  • K914958 — RIATRAC PLUS (March 18, 1992)
  • K915197 — PRECISE TM HCG (December 17, 1991)
  • K915200 — PRECISE TM HCG FOR USE IN THE PHYSICIANS OFFICE LA (December 16, 1991)

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)
  • 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)
  • K922945 — TECHNICON DAX SYSTEM THYROXINE (T4) METHOD (October 14, 1992)