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510(k) K032697

DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414) by Dade Behring, Inc. — Product Code JIS

K032697 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)". The FDA issued a decision of Substantially Equivalent on November 7, 2003. The device falls under product code JIS (Calibrator, Primary), a Class II device regulated under 21 CFR 862.1150. Dade Behring, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2003
Date Received
September 2, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Primary
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

Other clearances by Dade Behring, Inc.

  • K093848 — PT-MULTI-CALIBRATOR, MODEL OPAT07 (December 20, 2010)
  • K081161 — DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEI (July 28, 2008)
  • K081249 — DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROT (July 21, 2008)
  • K071603 — DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA) (June 25, 2008)
  • K071597 — DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (June 4, 2008)
  • K073604 — DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CAR (March 13, 2008)
  • K073561 — DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA (February 26, 2008)
  • K073072 — DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B (February 21, 2008)
  • K073055 — DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270 (January 3, 2008)
  • K072965 — DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON (December 21, 2007)

Other clearances for product code JIS

  • K122126 — DIRECT LDL/HDL CHOLESTEROL CALIBRATOR (August 14, 2012)
  • K061251 — DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR (May 31, 2006)
  • K060266 — DIMENSION IRON CALIBRATOR (March 9, 2006)
  • K053104 — DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR (December 23, 2005)
  • K032608 — GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER (October 21, 2003)
  • K032296 — VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS (August 13, 2003)
  • K030964 — CALIBRATION PLASMA LMW HEPARIN (June 6, 2003)
  • K030546 — CRP (II) CALIBRATORS (June 2, 2003)
  • K030320 — WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CON (April 11, 2003)
  • K022682 — RANDOX C-REACTIVE PROTEIN CALIBRATOR (November 5, 2002)

FDA data resources