Home / 510(k) Clearances / K855033

510(k) K855033

T-3 UPTAKE/RIASSAY by Ria Diagnostics — Product Code KHQ

K855033 is an FDA 510(k) premarket notification submitted by Ria Diagnostics for the device "T-3 UPTAKE/RIASSAY". The FDA issued a decision of Substantially Equivalent on January 24, 1986. The device falls under product code KHQ (Radioassay, Triiodothyronine Uptake), a Class II device regulated under 21 CFR 862.1715. Ria Diagnostics has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1986
Date Received
December 17, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioassay, Triiodothyronine Uptake
Device Class
Class II
Regulation Number
862.1715
Review Panel
CH
Submission Type

Other clearances by Ria Diagnostics

  • K854798 — T-4 RIASSAY (January 15, 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 KHQ

  • K981375 — ACE T UPTAKE REAGENT TU CALIBRATORS (June 10, 1998)
  • K980088 — T-UPTAKE MICROPLATE EIA (February 4, 1998)
  • K970539 — CHIRON DIAGNOSTICS ACS:180TU P (March 24, 1997)
  • K964308 — VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAK (November 27, 1996)
  • K961488 — ELECSYS T-UPTAKE ASSAY (June 12, 1996)
  • K954807 — CEDIA T UPTAKE ASSAY (December 21, 1995)
  • K951586 — T-UPTAKE EIA TEST (May 15, 1995)
  • K933414 — STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAY (November 22, 1994)
  • K934312 — AXSYM(TM) T-UPTAKE (June 21, 1994)
  • K935816 — VIDAS T UPTAKE (March 22, 1994)

FDA data resources