PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM— 510(k) K971716

Name: FDA 510(k) clearance K971716
Creator: U.S. Food and Drug Administration
Published: 1997-06-27

Substantially Equivalent

Bayer Corp.

FDA 510(k) clearance K971716 for PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM, Substantially Equivalent on 1997-06-27. Applicant: Bayer Corp.. Device class: 2.

Clearance details

Applicant: Bayer Corp.
Product code: Code LAR
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1997-05-09
Decision date: 1997-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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