MIF · Class II · 21 CFR 864.7320

FDA Product Code MIF: Prothrombin Fragment 1.2

Leading manufacturers include Organon Teknika Corp., Dade Behring, Inc. and Baxter Diagnostics, Inc..

6
Total
6
Cleared
128d
Avg days
1991
Since

FDA 510(k) Cleared Prothrombin Fragment 1.2 Devices (Product Code MIF)

6 devices
1–6 of 6
Cleared Dec 10, 2004
ENZYGNOST F+2 (MONOCLONAL) TEST KIT
K042687
Dade Behring, Inc.
Hematology · 72d
Cleared Mar 18, 1997
THROMBONOSTIKA F1.2
K964934
Organon Teknika Corp.
Hematology · 99d
Cleared Oct 18, 1996
TPP
K962176
Panbio, Inc.
Hematology · 135d
Cleared Nov 16, 1992
ENZYGNOST F 1+2
K922934
Behring Diagnostics, Inc.
Hematology · 151d
Cleared Jun 04, 1992
DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA
K920895
Baxter Diagnostics, Inc.
Hematology · 99d
Cleared Oct 31, 1991
THROMBONOSTIKA F1.2
K911434
Organon Teknika Corp.
Hematology · 212d

About Product Code MIF - Regulatory Context