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510(k) K760078

REAGENT, RIA TRIIODOTHYRONINE T3 (#200) by Oxford Laboratories, Inc. — Product Code CDP

K760078 is an FDA 510(k) premarket notification submitted by Oxford Laboratories, Inc. for the device "REAGENT, RIA TRIIODOTHYRONINE T3 (#200)". The FDA issued a decision of Substantially Equivalent on July 20, 1976. The device falls under product code CDP (Radioimmunoassay, Total Triiodothyronine), a Class II device regulated under 21 CFR 862.1710. Oxford Laboratories, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1976
Date Received
June 18, 1976
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 Oxford Laboratories, Inc.

  • K780912 — ADJUSTABLE DISPENSOR (June 28, 1978)
  • K760146 — SERUM, IGA GOAT ANTI-HUMAN ACID (July 20, 1976)
  • K760079 — REAGENT, THYROXINE T4 (#210) (July 20, 1976)
  • K760147 — SERUM, IGM ANTI-HUMAN ACID (July 20, 1976)
  • K760148 — SERUM, B1A GLOBULIN C3C GOAT ANTI-HUMAN (July 20, 1976)
  • K760143 — SERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMAN (July 20, 1976)
  • K760144 — SERUM, HAPTOGLOBIN GOAT ANTI-HUMAN ACID (July 20, 1976)
  • K760145 — SERUM, IGG GOAT ANTI-HUMAN ACID (July 19, 1976)

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)
  • K983439 — ABBOTT ARCHITECT FREE T3 (November 20, 1998)
  • K983434 — ABBOTT ARCHITECT TOTAL 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