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510(k) K082030

DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440 by Siemens Healthcare Diagnostics, Inc. — Product Code DLJ

K082030 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics, Inc. for the device "DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440". The FDA issued a decision of Substantially Equivalent on August 22, 2008. The device falls under product code DLJ (Calibrators, Drug Specific), a Class II device regulated under 21 CFR 862.3200. Siemens Healthcare Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2008
Date Received
July 17, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrators, Drug Specific
Device Class
Class II
Regulation Number
862.3200
Review Panel
TX
Submission Type

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  • K241165 — Atellica® IM High-Sensitivity Troponin I (TnIH) (July 25, 2024)

Other clearances for product code DLJ

  • K132090 — BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPIN (August 8, 2013)
  • K091617 — QMS LIDOCAINE CALIBRATORS, MODEL 0374678 (July 17, 2009)
  • K062182 — DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520 (September 14, 2006)
  • K062199 — DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430) (September 6, 2006)
  • K061503 — DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A) (June 22, 2006)
  • K060503 — DIMENSION TACR CALIBRATOR, MODEL DC107 (May 18, 2006)
  • K053108 — DIMENSION CSAE CYCLOSPORINE EXTENDED RANGE CALIBRATOR, MODEL DC108 (February 16, 2006)
  • K052015 — DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108 (September 12, 2005)
  • K033601 — LABONE MICRO-PLATE COTININE EIA (February 10, 2004)
  • K033246 — PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS (December 2, 2003)

FDA data resources