DU PONT ACA PLUS IMMUNOASSAY SYSTEM MB MCKMB METH.— 510(k) K922700

Name: FDA 510(k) clearance K922700
Creator: U.S. Food and Drug Administration
Published: 1992-08-20

Substantially Equivalent

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

FDA 510(k) clearance K922700 for DU PONT ACA PLUS IMMUNOASSAY SYSTEM MB MCKMB METH., Substantially Equivalent on 1992-08-20. Applicant: E.I. Dupont DE Nemours & Co., Inc.. Device class: 2.

Clearance details

Applicant: E.I. Dupont DE Nemours & Co., Inc.
Product code: Code JHY
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1992-06-04
Decision date: 1992-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, DE, US

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