510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K070987Substantially Equivalent

Sentinel Lithium Assay

Sentinel CH SpA, Milan, IT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070987 is the FDA 510(k) clearance record for SENTINEL LITHIUM ASSAY, a class II device, cleared for SENTINEL CH. SpA on under FDA product code NDW (Assay, Porphyrin, Spectrophotometry, Lithium). FDA records list 22 510(k) clearances for SENTINEL CH. SpA, from to . As of , FDA records show 2 recalls naming K070987.

Clearance record

Decision date
Received
(118 days to decision)
Product code
NDW Assay, Porphyrin, Spectrophotometry, Lithium
Regulation
21 CFR 862.3560
Device class
Class II
Review panel
Clinical Toxicology
Applicant
SENTINEL CH. SpA Via Robert Koch 2, Milan, IT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NDW

Trailing 12 months

FDA records hold no clearances under product code NDW in the trailing twelve months.

FDA records show no clearances under product code NDW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NDW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260