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510(k) K792539

TRIIODOTHYRONINE RIA SYSTEM by Radioimmunoassay, Inc. — Product Code CDP

K792539 is an FDA 510(k) premarket notification submitted by Radioimmunoassay, Inc. for the device "TRIIODOTHYRONINE RIA SYSTEM". The FDA issued a decision of Substantially Equivalent on January 16, 1980. The device falls under product code CDP (Radioimmunoassay, Total Triiodothyronine), a Class II device regulated under 21 CFR 862.1710. Radioimmunoassay, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 1980
Date Received
December 10, 1979
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 Radioimmunoassay, Inc.

  • K802135 — TESTOSTERONE RADIOIMMUNOASSY KIT (October 10, 1980)
  • K800107 — FOLLICLE STIMULATING HORMONE (February 13, 1980)
  • K800106 — LUTEINIZING HORMONE RADIOIMMUNOASSAY SYS (February 13, 1980)
  • K792153 — DIGOXIN RADIOIMMUNOASSAY SYSTEM (November 13, 1979)
  • K792154 — THYROID STIMULATING HORMONE (November 13, 1979)
  • K792036 — CORTISOL RADIOIMMUNOASSAY SYSTEM (October 30, 1979)
  • K780672 — 125 I-T4 RIA REAGENT (June 6, 1978)
  • K780671 — 125 I-T3 UPTAKE REAGENT (June 6, 1978)

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