Cleared Traditional

ENZYGNOST F 1+2

K922934 · Behring Diagnostics, Inc. · Hematology
Nov 1992
Decision
151d
Days
Class 2
Risk

About This 510(k) Submission

K922934 is an FDA 510(k) clearance for the ENZYGNOST F 1+2, a Prothrombin Fragment 1.2 (Class II — Special Controls, product code MIF), submitted by Behring Diagnostics, Inc. (Somerville, US). The FDA issued a Cleared decision on November 16, 1992, 151 days after receiving the submission on June 18, 1992. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7320.

Submission Details

510(k) Number K922934 FDA.gov
FDA Decision Cleared SESE
Date Received June 18, 1992
Decision Date November 16, 1992
Days to Decision 151 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code MIF — Prothrombin Fragment 1.2
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7320