Cleared Traditional

ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT

K941001 · Diagnostic Specialties · Hematology
Aug 1994
Decision
182d
Days
Class 2
Risk

About This 510(k) Submission

K941001 is an FDA 510(k) clearance for the ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT, a Test, Fibrinogen (Class II — Special Controls, product code GIS), submitted by Diagnostic Specialties (Metuchen, US). The FDA issued a Cleared decision on August 30, 1994, 182 days after receiving the submission on March 1, 1994. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7340.

Submission Details

510(k) Number K941001 FDA.gov
FDA Decision Cleared SESE
Date Received March 01, 1994
Decision Date August 30, 1994
Days to Decision 182 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code GIS — Test, Fibrinogen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7340

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