URINARY ALBUMIN CALIBRATOR— 510(k) K936201

Name: FDA 510(k) clearance K936201
Creator: U.S. Food and Drug Administration
Published: 1994-03-11

Substantially Equivalent

Dupont Medical Products

FDA 510(k) clearance K936201 for URINARY ALBUMIN CALIBRATOR, Substantially Equivalent on 1994-03-11. Applicant: Dupont Medical Products. Device class: 2.

Clearance details

Applicant: Dupont Medical Products
Product code: Code JIS
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 1993-12-29
Decision date: 1994-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: N. Billerica, MA, US

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