ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT— 510(k) K941001

Name: FDA 510(k) clearance K941001
Creator: U.S. Food and Drug Administration
Published: 1994-08-30

Substantially Equivalent

Diagnostic Specialties

FDA 510(k) clearance K941001 for ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT, Substantially Equivalent on 1994-08-30. Applicant: Diagnostic Specialties. Device class: 2.

Clearance details

Applicant: Diagnostic Specialties
Product code: Code GIS
Device class: Class 2
Regulation: 21 CFR 864.7340
Advisory panel: Hematology
Date received: 1994-03-01
Decision date: 1994-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Metuchen, NJ, US

Download summary PDF View on FDA.gov ↗

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