SENTINEL LITHIUM ASSAY— 510(k) K070987

Substantially Equivalent

SENTINEL CH. SpA

FDA 510(k) clearance K070987 for SENTINEL LITHIUM ASSAY, Substantially Equivalent on 2007-08-02. Applicant: SENTINEL CH. SpA. Device class: 2.

Clearance details

Applicant: SENTINEL CH. SpA
Product code: Code NDW
Device class: Class 2
Regulation: 21 CFR 862.3560
Advisory panel: Clinical Toxicology
Date received: 2007-04-06
Decision date: 2007-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milan, IT

Download summary PDF View on FDA.gov ↗

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More clearances from SENTINEL CH. SpA

Recalls naming K070987

K-number listed on FDA's recall record

Z-2551-2019 — MULTIGENT Lithium-intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 8L25-30Class II·Terminated·Sentinel CH SpA·20190628
Z-2552-2019 — Alinity c Lithium Reagent Kit- intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 08P5320Class II·Terminated·Sentinel CH SpA·20190628

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K070987.

Data sourced from openFDA. This site is unofficial and independent of the FDA.