N-ACETYLPROCAINAMIDE CALIBRATOR— 510(k) K833385

Name: FDA 510(k) clearance K833385
Creator: U.S. Food and Drug Administration
Published: 1983-12-16

Substantially Equivalent

E.I. Dupont DE Nemours & Co., Inc.

FDA 510(k) clearance K833385 for N-ACETYLPROCAINAMIDE CALIBRATOR, Substantially Equivalent on 1983-12-16. Applicant: E.I. Dupont DE Nemours & Co., Inc.. Device class: 1.

Clearance details

Applicant: E.I. Dupont DE Nemours & Co., Inc.
Product code: Code DLG
Device class: Class 1
Regulation: 21 CFR 862.2250
Advisory panel: Clinical Chemistry
Date received: 1983-09-29
Decision date: 1983-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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