KEOClass I

Formulations, Paraffin, All

Pathology · 21 CFR 864.4010

MDR events1All time

Recalls3All time

Registered firms25Currently listed

510(k) clearances11All time

Recent MDR events

1 adverse event reports on file

PARAFFIN PRETREATMENT KIT II AND KIT IIIDec 10, 2009
OtherAbbott Molecular, Inc.3005248192-2009-00005

Event type breakdown

Other1

Most-reported manufacturers

Abbott Molecular, Inc.1

Recalls

3 recall events for this product code

Sakura Finetek USA Inc
TerminatedJun 10, 2014
Tissue-Tek PARAFORM PROC/EMB/MEDIUM, FORMULA 3 - 8x1Kg.
This Lot has variations in melting temperature.
Z-1748-2014 · View FDA record ↗
Abbott Molecular
TerminatedMar 16, 2010
Paraffin Pretreatment Reagent Kit II; each kit contains the following: 5 x 50 mL Pretreatment Solution (sodium thiocyanate - NaSCN), 5 x 62.5 mL Protease Buffer
The Paraffin Pretreatment Reagent kits do not have any hazardous or MSDS information included in their labeling.
Z-1147-2010 · View FDA record ↗
Abbott Molecular
TerminatedMar 16, 2010
Paraffin Pretreatment Reagent Kit III; each kit contains the following:
The Paraffin Pretreatment Reagent kits do not have any hazardous or MSDS information included in their labeling.
Z-1148-2010 · View FDA record ↗

Registered firms

25 firms currently registered for this product code

510(k) clearances

11 clearances for this product code