TDM N-ACETYLPROCAINAMIDE— 510(k) K060738

Name: FDA 510(k) clearance K060738
Creator: U.S. Food and Drug Administration
Published: 2006-08-16

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K060738 for TDM N-ACETYLPROCAINAMIDE, Substantially Equivalent on 2006-08-16. Applicant: Roche Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code LAN
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 2006-03-20
Decision date: 2006-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LAN

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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
K955422 — AXSYM N-ACETYLPROCAINAMIDE1996-04-24

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