Cleared Traditional

DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA

K920895 · Baxter Diagnostics, Inc. · Hematology
Jun 1992
Decision
99d
Days
Class 2
Risk

About This 510(k) Submission

K920895 is an FDA 510(k) clearance for the DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA, a Prothrombin Fragment 1.2 (Class II — Special Controls, product code MIF), submitted by Baxter Diagnostics, Inc. (Miami, US). The FDA issued a Cleared decision on June 4, 1992, 99 days after receiving the submission on February 26, 1992. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7320.

Submission Details

510(k) Number K920895 FDA.gov
FDA Decision Cleared SESE
Date Received February 26, 1992
Decision Date June 04, 1992
Days to Decision 99 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