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510(k) K810212

DAC-CEL T3 UPTAKE by Burroughs Wellcome Co. — Product Code KHQ

K810212 is an FDA 510(k) premarket notification submitted by Burroughs Wellcome Co. for the device "DAC-CEL T3 UPTAKE". The FDA issued a decision of Substantially Equivalent on February 10, 1981. The device falls under product code KHQ (Radioassay, Triiodothyronine Uptake), a Class II device regulated under 21 CFR 862.1715. Burroughs Wellcome Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1981
Date Received
January 27, 1981
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 Burroughs Wellcome Co.

  • K820069 — WELLCOGEN GROUP B (February 18, 1982)
  • K813508 — SAC-CEL (December 29, 1981)
  • K810215 — DAC-CEL HCG (April 17, 1981)
  • K810214 — DAC-CEL DIAGNATAL (March 6, 1981)
  • K810213 — DAC-CEL TSH (February 10, 1981)
  • K791231 — DAC-CEL T4 (September 4, 1979)
  • K791232 — DAC-CEL T3 (September 4, 1979)
  • K781607 — STREP-TEX (October 17, 1978)
  • K780873 — THYMUNE-M (June 14, 1978)
  • K780874 — THYMUNE-T (June 14, 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