ClearanceBrief
510(k) K961481 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

ELECSYS 2010 ANALYZER

ApplicantBoehringer Mannheim Corp., Indianapolis IN, US
DecisionSubstantially Equivalent, Jun 14, 1996
ReceivedApr 18, 1996
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K961481

DateFirm and productCodeLinked 510(k)
Jul 5, 2017Roche Diagnostics Corporation
Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number: 11568248001/11568248692 - Elecsys 2010 analyzer (disk system) and 11804014001/11804014692 - Elecsys 2010 analyz
Terminated		 JJENone listed
Jul 15, 2016Roche Diagnostics Operations, Inc.
cobas e411 Immunoassay Analyzer e411: Immunoassay Analyzer Product Usage: The cobas p501/p701 instrument stores primary and secondary sample tubes. The tubes are stored in a controlled, refrigerated
Terminated		 JJENone listed
Jun 14, 2014Roche Diagnostics Operations, Inc.
Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully autom
Terminated		 JJENone listed
Mar 16, 2012Roche Diagnostics Operations, Inc.
Elecsys 2010 Analyzer Software version 06-07 The Elecsys 2010 analyzer is intended for the in vitro quantitative and qualitative analysis of analytes in body fluids.
Terminated		 JJENone listed
Oct 22, 2008Roche Diagnostics Corp.
Roche/Hitachi Modular E Module immunoassay analyzer, Roche Diagnostics, Ind., IN; GMMI Nos. 04998642001 and 03617505001.
Terminated		 JJENone listed
Aug 13, 2008Roche Diagnostics Corp.
Roche/Hitachi Modular Analytics System, Modular E Module GMMI immunoassay analyzer; Catalog numbers 04998642001 and 03617505001. Intended for qualitative and quantitative in vitro determinations usi
Terminated		 JJENone listed

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