PHENOBARBITAL FLEX REAGENT CARTRIDGE— 510(k) K944932

Name: FDA 510(k) clearance K944932
Creator: U.S. Food and Drug Administration
Published: 1994-12-28

Substantially Equivalent

Dupont Medical Products

FDA 510(k) clearance K944932 for PHENOBARBITAL FLEX REAGENT CARTRIDGE, Substantially Equivalent on 1994-12-28. Applicant: Dupont Medical Products. Device class: 2.

Clearance details

Applicant: Dupont Medical Products
Product code: Code DLZ
Device class: Class 2
Regulation: 21 CFR 862.3660
Advisory panel: Clinical Toxicology
Date received: 1994-10-06
Decision date: 1994-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, DE, US

Download summary PDF View on FDA.gov ↗

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