JPFClass II

Prothrombin-proconvertin And Thrombotest

Hematology · 21 CFR 864.7735

MDR events1All time

Recalls1All time

Registered firms1Currently listed

510(k) clearances0All time

Recent MDR events

1 adverse event reports on file

H-WAVE E STIMULATORNov 21, 2000
InjuryElectronic Wave Form, Lab Inc.MW1020473

Event type breakdown

Injury1

Most-reported manufacturers

Electronic Wave Form, Lab Inc.1

Recalls

1 recall events for this product code

Roche Molecular Systems, Inc.
TerminatedJun 14, 2011
Factor II (Prothrombin) G20210A Kit Light Cycler Instrument; Manufactured in Germany for Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA DisFor use with
Roche Molecular Systems has decided to discontinue marketing the Factor II (Prothrombin) G20210A Kit and the Factor V Leiden Kit for use with the Light Cycler 2.0 Instrument in the US Market
Z-2565-2011 · View FDA record ↗

Registered firms

1 firms currently registered for this product code

Sts Corporation
Duluth, GA, US

510(k) clearances

0 clearances for this product code

No 510(k) clearances on file for this product code.