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510(k) K922945

TECHNICON DAX SYSTEM THYROXINE (T4) METHOD by Heraeus Kulzer, Inc. — Product Code CDX

K922945 is an FDA 510(k) premarket notification submitted by Heraeus Kulzer, Inc. for the device "TECHNICON DAX SYSTEM THYROXINE (T4) METHOD". The FDA issued a decision of Substantially Equivalent on October 14, 1992. The device falls under product code CDX (Radioimmunoassay, Total Thyroxine), a Class II device regulated under 21 CFR 862.1700. Heraeus Kulzer, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1992
Date Received
June 18, 1992
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 Heraeus Kulzer, Inc.

  • K130647 — XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FAST SET CARTRIDGE -6 X (May 17, 2013)
  • K123278 — IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF (December 7, 2012)
  • K120914 — FLEXITIME FAST & SCAN LIGHT FLOW (July 25, 2012)
  • K113574 — FLEXITIME MONOPHASE PRO SCAN (July 13, 2012)
  • K112501 — VENUS PEARL PLT REFILL A1 (December 14, 2011)
  • K111832 — PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID (September 29, 2011)
  • K110037 — PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUID (April 29, 2011)
  • K102770 — FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCA (December 21, 2010)
  • K101617 — FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CAR (September 7, 2010)
  • K093575 — GLUMA DESENSITIZER POWER GEL (March 5, 2010)

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