ClearanceBrief
510(k) K102779 ยท DJG Enzyme Immunoassay, Opiates

EMIT II PLUS6-ACETYLMORPHINE ASSAY; EMIT II PLUS 6-AM/ ECSTASY CALIBRATOR/ CONTROL LEVEL 1; EMIT II PLUS 6-AM / ECTASY C

ApplicantSiemens Healthcare Diagnostics, Inc., Newark DE, US
DecisionSubstantially Equivalent, Mar 18, 2011
ReceivedSep 24, 2010
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K102779

DateFirm and productCodeLinked 510(k)
Mar 12, 2018Siemens Healthcare Diagnostics, Inc.
Syva EMIT II Plus 6-Acetylmorphine Catalog # for 1000 mL: 9R129UL /SMN# 10481483
Terminated		 DJGNone listed
Mar 12, 2018Siemens Healthcare Diagnostics, Inc.
Syva EMIT II Plus 6-Acetyl morphine Catalog # for 28 mL: 9R039UL /SMN# 10470440
Terminated		 DJGNone listed

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