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510(k) K833745

RIACOAT T-4 by Immuno Assay Corp. — Product Code CDX

K833745 is an FDA 510(k) premarket notification submitted by Immuno Assay Corp. for the device "RIACOAT T-4". The FDA issued a decision of Substantially Equivalent on January 4, 1984. The device falls under product code CDX (Radioimmunoassay, Total Thyroxine), a Class II device regulated under 21 CFR 862.1700. Immuno Assay Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 1984
Date Received
October 26, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Total Thyroxine
Device Class
Class II
Regulation Number
862.1700
Review Panel
CH
Submission Type

Other clearances by Immuno Assay Corp.

  • K833842 — RIA COAT DIGOXIN (January 17, 1984)
  • K820089 — TSH (RIA) KIT (January 28, 1982)
  • K820074 — CORTISOL (RIA) KIT (January 28, 1982)
  • K811954 — COMBO-FER IRON DIAGNOSTIC (July 27, 1981)
  • K811725 — TBG DIAGNOSTIC KIT (July 10, 1981)
  • K811213 — T3 (RIA) KIT (May 29, 1981)
  • K811212 — DIGOXIN (RIA) KIT (May 21, 1981)
  • K810857 — T3 UPTAKE KIT (April 8, 1981)
  • K810811 — T4 RIA KIT (April 7, 1981)

Other clearances for product code CDX

  • K961490 — ELECSYS T4 ASSAY (June 13, 1996)
  • K954312 — ACTIVE THYROXINE RIA (October 7, 1995)
  • K943416 — DELFIA NEONATAL THYROXINE KIT (March 10, 1995)
  • K934384 — AXSYM(TM) TOTAL T4 (June 21, 1994)
  • K932980 — TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116 (October 18, 1993)
  • K933426 — STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO (August 26, 1993)
  • K931295 — IQ TT4 ASSAY (July 20, 1993)
  • K926563 — AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KIT (March 18, 1993)
  • K925110 — ABBOTT IMX T4 (January 26, 1993)
  • K925109 — ABBOTT TDX/TDXFLX TT4 (January 4, 1993)

FDA data resources