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510(k) K070987

SENTINEL LITHIUM ASSAY by SENTINEL CH. SpA — Product Code NDW

K070987 is an FDA 510(k) premarket notification submitted by SENTINEL CH. SpA for the device "SENTINEL LITHIUM ASSAY". The FDA issued a decision of Substantially Equivalent on August 2, 2007. The device falls under product code NDW (Assay, Porphyrin, Spectrophotometry, Lithium), a Class II device regulated under 21 CFR 862.3560. SENTINEL CH. SpA has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2007
Date Received
April 6, 2007
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 SENTINEL CH. SpA

  • K242585 — Cystatin C (May 16, 2025)
  • K211058 — Lp(a) Ultra (December 22, 2022)
  • K193001 — Albumin BCP (December 19, 2019)
  • K192118 — CRP Vario (November 8, 2019)
  • K173833 — CRP Vario (September 27, 2018)
  • K141728 — ACE CALIBRATOR (July 28, 2014)
  • K102706 — CKMB UDR ASSAY (August 19, 2011)
  • K083602 — KAPPA LIGHT CHAINS (September 3, 2009)
  • K083601 — LAMBDA LIGHT CHAINS (June 22, 2009)
  • K081533 — SENTINEL PLASMAPROTEINS CAL 3X (June 25, 2008)

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)
  • K050374 — ADVIA IMS LITHIUM ASSAY (June 15, 2005)
  • K003583 — LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901 (January 17, 2001)

FDA data resources