Home / 510(k) Clearances / K780492

510(k) K780492

GAMMA STIK 125I T3 UPTAKE KIT by Alpha Gamma Laboratory — Product Code CDP

K780492 is an FDA 510(k) premarket notification submitted by Alpha Gamma Laboratory for the device "GAMMA STIK 125I T3 UPTAKE KIT". The FDA issued a decision of Substantially Equivalent on April 28, 1978. The device falls under product code CDP (Radioimmunoassay, Total Triiodothyronine), a Class II device regulated under 21 CFR 862.1710. Alpha Gamma Laboratory has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 1978
Date Received
March 27, 1978
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 Alpha Gamma Laboratory

  • K810011 — GAMMA STICK 125-1 TOBRAMYCIN RIA KIT (January 28, 1981)
  • K800537 — GAMMA STICK GENTAMICIN RIA KIT (April 24, 1980)
  • K800538 — GAMMA STICK CORTISOL RIA KIT/STICK KIT (April 24, 1980)

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