510(k) K953239 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
BOEHRINGER MANNHEIM/HITACHI 917 ANALYZER
| Applicant | Boehringer Mannheim Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Sep 25, 1995 |
| Received | Jul 11, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953239
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 16, 2018 | Roche Diagnostics Corporation Brand Name:
cobas c 6000 MODULAR Series System e 601
cobas c 8000 MODULAR Series System - e 602
Roche / Hitachi MODULAR Analytics Combination System
Model/Catalog/Part Number:
MODULAR Analytics Terminated |
JJE | None listed |
| Dec 18, 2017 | Roche Diagnostics Corporation Modular E 170 Analyzer: Immunoassay Chemistry Analyzer, Chemistry
(Photometric, Discrete) for clinical use, Catalog Numbers: 03739040692,
03023109001, 05023599001, 05023572001, 03739040001 & 030231099 Terminated |
JJE | None listed |
| Jul 15, 2016 | Roche Diagnostics Operations, Inc. Roche/Hitachi MODULAR Analytics Combination Systems
Modular D/P: Clinical Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use. Modular E170: Immunoassay Analyzer
Product Usage:
The Terminated |
JJE | None listed |
| Jun 27, 2015 | Roche Diagnostics Operations, Inc. Creatinine Plus.
Intended for use on Hitachi/MODULAR systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine. Terminated |
JJE | None listed |
| Apr 10, 2009 | Roche Diagnostics Corp. Roche/Hitachi Modular Analytics System, clinical chemistry analyzer Modular D2400 Module, Roche Diagnostics Corp., Indpls., IN; GMMI No. 04998618001.
Is a fully automatic, computerized chemistry ana Terminated |
JJE | None listed |
| Apr 10, 2009 | Roche Diagnostics Corp. Roche/Hitachi Modular Analytics System, clinical chemistry analyzer, Modular P800 Module, Roche Diagnostics Corp., Indpls., IN; GMMI No. 04998669001.
Is a fully automatic, computerized chemistry anal Terminated |
JJE | None listed |
| Apr 10, 2009 | Roche Diagnostics Corp. Roche/Hitachi Modular Analytics System, clinical chemistry analyzer, Modular D Module, Roche Diagnostics Corp., Indpls., IN; GMMI No. 03284522001.
Is a fully automatic, computerized chemistry analyze Terminated |
JJE | None listed |
| Apr 10, 2009 | Roche Diagnostics Corp. Roche/Hitachi Modular Analytics System, clinical chemistry analyzer, Modular P Module, Roche Diagnostics Corp., Indpls., IN; GMMI No. 03284549001.
Is a fully automatic, computerized chemistry analyze Terminated |
JJE | None listed |
| Aug 13, 2008 | Roche Diagnostics Corp. Roche/Hitachi Modular Analytics System, Modular D2400 Module GMMI clinical chemistry analyzer; Catalog number 04998618001.
Intended for qualitative and quantitative in vitro determinations using a wi Terminated |
JJE | None listed |
| Aug 13, 2008 | Roche Diagnostics Corp. Roche/Hitachi Modular Analytics System, Modular P800 Module GMMI clinical chemistry analyzer; Catalog number 04998669001.
Intended for qualitative and quantitative in vitro determinations using a wid Terminated |
JJE | None listed |
| Aug 13, 2008 | Roche Diagnostics Corp. Roche/Hitachi Modular Analytics System, Modular D Module GMMI clinical chemistry analyzer; Catalog number 03284522001.
Intended for qualitative and quantitative in vitro determinations using a wide v Terminated |
JJE | None listed |
| Aug 13, 2008 | Roche Diagnostics Corp. Roche/Hitachi Modular Analytics System Modular P Module GMMI immunoassay analyzer; Catalog number 03284549001.
Intended for qualitative and quantitative in vitro determinations using a wide variety o Terminated |
JJE | None listed |
| Aug 29, 2006 | Roche Diagnostics Corp. Roche/Hitachi K Electrode, a potassium electrode for use with the Roche/Hitachi models 717,747, 902, 911,912, 917, Modular and Cobas c 501clinical chemistry analyzers; Roche Catalog/Part Number 108254 Terminated |
CEM | None listed |
| Aug 3, 2006 | Roche Diagnostics Corp. Roche/Hitachi K Electrode, a potassium electrode for use with the Roche/Hitachi models 717,747, 902, 911,912, 917, Modular and cobas c 501 clinical chemistry analyzers; Roche Catalog/Part Number 10825 Terminated |
CEM | None listed |
| Sep 2, 2004 | Roche Diagnostics Corp. Roche/Hitachi Modular Analytical D Module clinical chemistry analyzer; catalog number 03739023001. Terminated |
JJE | None listed |
| Sep 2, 2004 | Roche Diagnostics Corp. Roche/Hitachi Modular Analytical D Module DAT clinical chemistry analyzer; catalog number 04429338160. Terminated |
JJE | None listed |
| Sep 2, 2004 | Roche Diagnostics Corp. Roche/Hitachi Modular Additional D Module DAT clinical chemistry analyzer; catalog number 04429389160. Terminated |
JJE | None listed |
| Oct 15, 2003 | Roche Diagnostics Corp. Roche/Hitachi Modular Analytics P clinical chemistry analyzer; Modular P. Catalog number 766-8156. Terminated |
None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.