DUPONT DIMENSION AMYLASE METHOD— 510(k) K942640

Substantially Equivalent

Dupont Medical Products

FDA 510(k) clearance K942640 for DUPONT DIMENSION AMYLASE METHOD, Substantially Equivalent on 1994-09-09. Applicant: Dupont Medical Products. Device class: 2.

Clearance details

Applicant
Dupont Medical Products
Product code
Code JFJ
Device class
Class 2
Regulation
21 CFR 862.1070
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Wilmington, DE, US
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