QMS QUINIDINE. QMS QUINIDINE CALIBRATORS— 510(k) K052826

Name: FDA 510(k) clearance K052826
Creator: U.S. Food and Drug Administration
Published: 2005-12-23

Substantially Equivalent

Seradyn, Inc.

FDA 510(k) clearance K052826 for QMS QUINIDINE. QMS QUINIDINE CALIBRATORS, Substantially Equivalent on 2005-12-23. Applicant: Seradyn, Inc.. Device class: 2.

Clearance details

Applicant: Seradyn, Inc.
Product code: Code LBZ
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 2005-10-05
Decision date: 2005-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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K964212 — QUINIDINE ENZYME IMMUNOASSAY1996-12-18
K955568 — INNOFLUOR QUINIDINE ASSAY SYSTEM1996-04-04

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