IDTClass I

Apparatus, Melting Point, Paraffin

Pathology · 21 CFR 864.3010

MDR events1All time

Recalls1All time

Registered firms6Currently listed

510(k) clearances0All time

Recent MDR events

1 adverse event reports on file

CELLIENT PROCESSORMay 17, 2018
MalfunctionHologic Inc.1222780-2018-00091

Event type breakdown

Malfunction1

Most-reported manufacturers

Recalls

1 recall events for this product code

Richard-Allan Scientific Company
TerminatedUnknown
Richard-Allan Scientific Paraffin Type 3
Multiple complaints were received from customers indicating that they ordered product 8335(Type 3 Paraffin) but when they opened the box, they found product 8336 (Type 6 Paraffin) inside.
Z-1319-2016 · View FDA record ↗

Registered firms

6 firms currently registered for this product code

510(k) clearances

0 clearances for this product code

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