N-ACETYLPROCAINAMIDE (NAPA) (FPIA) KIT— 510(k) K895571

Name: FDA 510(k) clearance K895571
Creator: U.S. Food and Drug Administration
Published: 1989-10-25

Substantially Equivalent

Tudor Laboratories, Inc.

FDA 510(k) clearance K895571 for N-ACETYLPROCAINAMIDE (NAPA) (FPIA) KIT, Substantially Equivalent on 1989-10-25. Applicant: Tudor Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Tudor Laboratories, Inc.
Product code: Code LAN
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1989-09-06
Decision date: 1989-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LAN

view all

K060738 — TDM N-ACETYLPROCAINAMIDE2006-08-16
K032564 — DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF1112003-10-31
K011620 — EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N2292001-06-18
K983812 — NAPA EIA ASSAY1998-11-16
K971713 — N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM1997-06-11

More clearances from Tudor Laboratories, Inc.

view all

K921904 — THYROXINE (FPIA) KIT1992-06-24
K921903 — THYROXINE CALIBRATOR KIT1992-05-26
K913240 — DIGITOXIN (FPIA) KIT1991-09-06
K895572 — N-ACETYLPROCAINAMIDE (NAPA) CALIBRATOR KIT1989-10-30
K895567 — PRIMIDONE (FPIA) KIT1989-10-20

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