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510(k) K103360

DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL by Siemens Corp. — Product Code JIT

K103360 is an FDA 510(k) premarket notification submitted by Siemens Corp. for the device "DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL". The FDA issued a decision of Substantially Equivalent on December 17, 2010. The device falls under product code JIT (Calibrator, Secondary), a Class II device regulated under 21 CFR 862.1150. Siemens Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2010
Date Received
November 16, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Siemens Corp.

  • K150843 — syngo®.via (version VB10A) (April 24, 2015)
  • K123375 — SYNGO.VIA (November 20, 2012)
  • K110366 — SYNGO.CT CARDIAC FUNCTION (April 12, 2011)
  • K081182 — MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST - INDUCIBL (August 8, 2008)
  • K071310 — SYNGO CT ONCOLOGY SOFTWARE PACKAGE (June 8, 2007)
  • K063507 — SYNGO NEURO PBV CT (November 30, 2006)
  • K063373 — FLEX LOOP COIL SET 3T (November 17, 2006)
  • K053024 — SYNGO NEURO DSA CT (November 4, 2005)
  • K050867 — SYNGO BODY PERFUSION-CT (April 14, 2005)
  • K043122 — SMD 21500 OR DSB-2103-D-5MP-5M PIXEL GRAYSCALE FLAT PANEL DISPLAY (February 9, 2005)

Other clearances for product code JIT

  • K171168 — VITROS Immunodiagnostic Products Insulin Calibrators (May 16, 2017)
  • K170938 — CalSet IGF-1 (April 26, 2017)
  • K170160 — Abbott ARCHITECT Free T3 (February 15, 2017)
  • K163546 — Lumipulse G Progesterone-N Calibrators (January 13, 2017)
  • K163534 — Lumipulse G FSH-N Calibrators (January 13, 2017)
  • K163521 — Lumipulse G LH Calibrators (January 12, 2017)
  • K163544 — Lumipulse G Prolactin (January 12, 2017)
  • K163078 — DC-UIBC-CAL (December 8, 2016)
  • K163053 — Lumipulse G E2-III Calibrators (December 1, 2016)
  • K162538 — ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Cal (November 17, 2016)

FDA data resources