Home / 510(k) Clearances / K854798

510(k) K854798

T-4 RIASSAY by Ria Diagnostics — Product Code CDX

K854798 is an FDA 510(k) premarket notification submitted by Ria Diagnostics for the device "T-4 RIASSAY". The FDA issued a decision of Substantially Equivalent on January 15, 1986. The device falls under product code CDX (Radioimmunoassay, Total Thyroxine), a Class II device regulated under 21 CFR 862.1700. Ria Diagnostics has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 1986
Date Received
December 2, 1985
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 Ria Diagnostics

  • K855033 — T-3 UPTAKE/RIASSAY (January 24, 1986)
  • K852537 — T-3 RIASSAY (August 12, 1985)
  • K810296 — DIGOXIN RIA ASSAY (February 19, 1981)
  • K801691 — TSH RIASSAY (August 27, 1980)
  • K792062 — THEOPHYLLINE RIASSAY (February 25, 1980)
  • K780012 — ANTITHROMBIN III RIA (January 20, 1978)

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)

FDA data resources