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510(k) K791361

T3 UPTAKE RADIOIMMUNOASSAY KIT by Technia Diagnostics , Ltd. — Product Code KHQ

K791361 is an FDA 510(k) premarket notification submitted by Technia Diagnostics , Ltd. for the device "T3 UPTAKE RADIOIMMUNOASSAY KIT". The FDA issued a decision of Substantially Equivalent on August 16, 1979. The device falls under product code KHQ (Radioassay, Triiodothyronine Uptake), a Class II device regulated under 21 CFR 862.1715. Technia Diagnostics , Ltd. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 1979
Date Received
July 20, 1979
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 Technia Diagnostics , Ltd.

  • K861978 — AUTOFLUOR V (June 10, 1986)
  • K801843 — T3(125) RADIOIMMUNOASSAY KIT (September 16, 1980)
  • K801202 — DIGOXIN RADIOIMMUNOASSAY KIT (June 20, 1980)
  • K801203 — CORTISOL RADIOIMMUNOASSAY KIT (June 9, 1980)
  • K790919 — HPL RIA KIT (June 28, 1979)
  • K790495 — THYROXINE RIA KIT (May 3, 1979)
  • K782024 — RIA KIT, VITAMIN B12 (February 28, 1979)
  • K782025 — GENTAMICIN FLUROIMMUNASSAY KIT (January 26, 1979)

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