Home / 510(k) Clearances / K810351

510(k) K810351

RADIOIMMUNOASSAY, TOTAL TRIIODOTHRONIE by Endocrine-Metabolic Center — Product Code CDP

K810351 is an FDA 510(k) premarket notification submitted by Endocrine-Metabolic Center for the device "RADIOIMMUNOASSAY, TOTAL TRIIODOTHRONIE". The FDA issued a decision of Substantially Equivalent on February 23, 1981. The device falls under product code CDP (Radioimmunoassay, Total Triiodothyronine), a Class II device regulated under 21 CFR 862.1710. Endocrine-Metabolic Center has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 1981
Date Received
February 10, 1981
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 Endocrine-Metabolic Center

  • K821131 — RADIOIMMUNOASSAY PARATHYROID HORMONE MID (June 2, 1982)
  • K811993 — RADIOIMMUNOASSAY, FOLLICLE STIMULATING (August 3, 1981)
  • K811994 — RADIOIMMUNOASSAY LUTEINIZING HORMONE (July 27, 1981)
  • K810948 — RADIOIMMUNOASSAY THYROID STIM. HORM. KIT (April 17, 1981)
  • K800187 — EMC-M-175, THYROXINE - 100 TUBES (February 13, 1980)
  • K800188 — EMC-M-180, T3 UPTAKE - 100 TUBES (February 13, 1980)
  • K790602 — RIA, DIGNXIN-125-I (July 30, 1979)
  • K790630 — RIA, INSULIN, DOUBLE ANTIBODY (July 24, 1979)

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