510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K895571Substantially Equivalent

N-Acetylprocainamide (Napa) (Fpia) Kit

Tudor Laboratories, Inc., Dallas TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895571 is the FDA 510(k) clearance record for N-ACETYLPROCAINAMIDE (NAPA) (FPIA) KIT, a class II device, cleared for Tudor Laboratories, Inc. on under FDA product code LAN (Enzyme Immunoassay, N-Acetylprocainamide). FDA records list 9 510(k) clearances for Tudor Laboratories, Inc., from to . As of , FDA records show no recalls naming K895571.

Clearance record

Decision date
Received
(49 days to decision)
Product code
LAN Enzyme Immunoassay, N-Acetylprocainamide
Regulation
21 CFR 862.3320
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Tudor Laboratories, Inc. 5910 N. Central Expy., Dallas TX
Third party review
No

Clearances, product code LAN

Trailing 12 months

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

FDA records show no clearances under product code LAN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LAN, 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