TDX N-ACETYLPROCAINAMIDE— 510(k) K830206

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K830206 for TDX N-ACETYLPROCAINAMIDE, Substantially Equivalent on 1983-02-18. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code LAN
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1983-01-21
Decision date: 1983-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, 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

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