DUPONT ACA PLUS LUTEINIZING HORMONE (LH) METHOD— 510(k) K943996

Name: FDA 510(k) clearance K943996
Creator: U.S. Food and Drug Administration
Published: 1994-10-20

Substantially Equivalent

Dupont Medical Products

FDA 510(k) clearance K943996 for DUPONT ACA PLUS LUTEINIZING HORMONE (LH) METHOD, Substantially Equivalent on 1994-10-20. Applicant: Dupont Medical Products. Device class: 1.

Clearance details

Applicant: Dupont Medical Products
Product code: Code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1994-08-16
Decision date: 1994-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: N. Billerica, MA, US

Download summary PDF View on FDA.gov ↗

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