DUPONT ACA PLUS IMMUNOASSAY SYSTEM FOLLICLE STIMULATING HORMONE— 510(k) K941221

Name: FDA 510(k) clearance K941221
Creator: U.S. Food and Drug Administration
Published: 1994-07-20

Substantially Equivalent

Dupont Medical Products

FDA 510(k) clearance K941221 for DUPONT ACA PLUS IMMUNOASSAY SYSTEM FOLLICLE STIMULATING HORMONE, Substantially Equivalent on 1994-07-20. Applicant: Dupont Medical Products. Device class: 1.

Clearance details

Applicant: Dupont Medical Products
Product code: Code CGJ
Device class: Class 1
Regulation: 21 CFR 862.1300
Advisory panel: Clinical Chemistry
Date received: 1994-03-14
Decision date: 1994-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, DE, US

Download summary PDF View on FDA.gov ↗

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