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510(k) K050374

ADVIA IMS LITHIUM ASSAY by Bayer Healthcare, LLC — Product Code NDW

K050374 is an FDA 510(k) premarket notification submitted by Bayer Healthcare, LLC for the device "ADVIA IMS LITHIUM ASSAY". The FDA issued a decision of Substantially Equivalent on June 15, 2005. The device falls under product code NDW (Assay, Porphyrin, Spectrophotometry, Lithium), a Class II device regulated under 21 CFR 862.3560. Bayer Healthcare, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2005
Date Received
February 14, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Porphyrin, Spectrophotometry, Lithium
Device Class
Class II
Regulation Number
862.3560
Review Panel
TX
Submission Type

Other clearances by Bayer Healthcare, LLC

  • K171802 — ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) (March 7, 2018)
  • K152852 — ALEVE Direct Therapy (ALEVE Direct Therapy TENS device) (December 22, 2015)
  • K150942 — Contour Next USB Blood Glucose Monitoring System (November 25, 2015)
  • K151742 — Contour Next Control Solution (September 23, 2015)
  • K130265 — CONTOUR NEXT EZ BLOOD GLUCOSE METER (June 23, 2014)
  • K122370 — CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR (September 26, 2013)
  • K121190 — CONTOUR NEXT BLOOD GLUCOSE METER (July 26, 2012)
  • K121087 — CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM (June 28, 2012)
  • K110894 — CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER (March 28, 2012)
  • K110587 — CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CON (March 28, 2012)

Other clearances for product code NDW

  • K243462 — Diazyme Colorimetric Lithium Assay (August 1, 2025)
  • K112142 — DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE (November 4, 2011)
  • K063684 — COBAS LITHIUM (March 21, 2008)
  • K063705 — LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CA (October 9, 2007)
  • K070987 — SENTINEL LITHIUM ASSAY (August 2, 2007)
  • K003583 — LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901 (January 17, 2001)

FDA data resources