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510(k) K852537

T-3 RIASSAY by Ria Diagnostics — Product Code CDP

K852537 is an FDA 510(k) premarket notification submitted by Ria Diagnostics for the device "T-3 RIASSAY". The FDA issued a decision of Substantially Equivalent on August 12, 1985. The device falls under product code CDP (Radioimmunoassay, Total Triiodothyronine), a Class II device regulated under 21 CFR 862.1710. Ria Diagnostics has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1985
Date Received
June 14, 1985
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 Ria Diagnostics

  • K855033 — T-3 UPTAKE/RIASSAY (January 24, 1986)
  • K854798 — T-4 RIASSAY (January 15, 1986)
  • 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 CDP

  • K001607 — REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104) (October 5, 2000)
  • K991692 — CHIRON DIAGNOSTICS ACS: 180 FT3 (June 18, 1999)
  • 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)

FDA data resources