ClearanceBrief
510(k) K972673 ยท JFP Electrode, Ion Specific, Calcium

AVL 9181 ELECTROLYTE ANALYZER

ApplicantAvl Scientific Corp., Roswell GA, US
DecisionSubstantially Equivalent, Aug 20, 1997
ReceivedJul 16, 1997
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K972673

DateFirm and productCodeLinked 510(k)
Mar 11, 2005Roche Diagnostics Corp.
Roche brand ISE SnapPak for use only in the AVL 9120/9130 Electrolyte Analyzer Assembled and distributed by Roche Diagnostics Corp., Indpls., IN; Ref/No. 03112276180; Part number BP5016.
Terminated		 None listed
Mar 11, 2005Roche Diagnostics Corp.
Roche brand ISE SnapPak for use only in the AVL 9180/9181 Electrolyte Analyzer Assembled and distributed by Roche Diagnostics Corp., Indpls., IN.; Ref/No. 03112349180, Part number BP5186.
Terminated		 None listed
Mar 11, 2005Roche Diagnostics Corp.
Roche brand ISE SnapPak for use only in the AVL 9110/9140 Electrolyte Analyzer Assembled and distributed by Roche Diagnostics Corp., Indpls., IN.; Ref/No. 03112314018, Part number BP5032.
Terminated		 None listed
Mar 11, 2005Roche Diagnostics Corp.
Bayer brand Technicon RA/opeRA Systems ISE Fluid Pack for in vitro diagnostic use on the opeRA system only, Manufacturer part number T01-3606-01, Mfd for Bayer Corporation, 511 Benedict Ave, Tarrytown
Terminated		 None listed
Mar 11, 2005Roche Diagnostics Corp.
Alfa Wassermann brand REF E1-8 STARLYTE III ISE Fluid Pack for use in the STARLYTE III electrolyte analyzer, Roche part number 03361152001.
Terminated		 None listed
Mar 11, 2005Roche Diagnostics Corp.
AVL Scientific Corp. brand 9180 SnapPak Type D, BP5206, for use only in the AVL 9180 electrolyte analyzer, Roche part number 03112357182.
Terminated		 None listed
Mar 11, 2005Roche Diagnostics Corp.
Vital Scientific brand ISE Snap Pack for use only in the ISE Module 9130, Ref no. 3203-007, Roche part number 03522032001.
Terminated		 None listed

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