510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K003583Substantially Equivalent

Lithium Regent Model Tr66056 / Lithium Standard Tr66901

Trace America, Inc., Arlington TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003583 is the FDA 510(k) clearance record for LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901, a class II device, cleared for Trace America, Inc. on under FDA product code NDW (Assay, Porphyrin, Spectrophotometry, Lithium). FDA records list 22 510(k) clearances for Trace America, Inc., from to . As of , FDA records show no recalls naming K003583.

Clearance record

Decision date
Received
(58 days to decision)
Product code
NDW Assay, Porphyrin, Spectrophotometry, Lithium
Regulation
21 CFR 862.3560
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Trace America, Inc. 845 Ave. G E., Arlington TX
510(k) summary
Statement
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