ClearanceBrief
510(k) BK130006

BK130006

This number appears on FDA recall records but not in the 510(k) decision file we hold.

Recalls that name BK130006

DateFirm and productCodeLinked 510(k)
Jul 2, 2013Ortho-Clinical Diagnostics
ORTHO Assay Software (OAS) Server, Catalog # 6842840 Usage: The ORTHO Summit System (OSS) is a modular, integrated system for use with licensed blood screening tests. Consisting of networked processo
Terminated
MZANone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.