510(k) K060373 ยท CEM Electrode, Ion Specific, Potassium
COBAS 6000 SERIES SYSTEM
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Mar 13, 2006 |
| Received | Feb 13, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060373
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 18, 2019 | Roche Diagnostics Operations, Inc. cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001 Terminated |
JJE | None listed |
| 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 c6000, Chemistry (Photometric, Discrete), for clinical use. - cobas e 601 module: Immunoassay Analyzer, Catalog Numbers: 04745922001, 05036348001, 05860652001, 04745922692, 05036348001 & 05036348692 Terminated |
JJE | None listed |
| Jul 18, 2017 | Roche Diagnostics Corporation cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 058 Terminated |
JJE | None listed |
| Mar 21, 2017 | Roche Diagnostics Corporation Sample probes associated with:
cobas 6000 Series System, cobas 8000 Modular Analyzer Series, cobas c 311 analyzer
cobas c 501/502
cobas c 701/702
cobas 8000 ISE
Product Usage:
The cobas 6000 series Terminated |
JJE | None listed |
| Jul 15, 2016 | Roche Diagnostics Operations, Inc. cobas 6000 Series system
c6000, Chemistry (Photometric, Discrete), for clinical Use. Modular e601: Immunoassay Analyzer
Product Usage:
The cobas p501/p701 instrument stores primary and secondary samp Terminated |
JJE | None listed |
| Jun 14, 2014 | Roche Diagnostics Operations, Inc. cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N)
Product Usage:
Fully automated immunoassay analyzer intended f Terminated |
JJE | None listed |
| Jun 14, 2014 | Roche Diagnostics Operations, Inc. cobas 8000 analyzer series Operators Manual Roche cobas
Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N)
Product Usage: Fully automated immunoassay analyzer intended f Terminated |
JJE | None listed |
| Jan 6, 2009 | Roche Diagnostics Corp. Roche ISE Internal Standard Gen.2 for use on Roche cobas c systems, Roche Diagnostics, Inc., Indpls., IN; Catalog no. 04522320190. Product is an in vitro diagnostic. Terminated |
JIX | None listed |
| Mar 4, 2008 | Roche Diagnostics Corp. Roche COBAS 6000 Clinical Chemistry analyzer; Catalog Number: 04745914001, Roche Diagnostics Corporation, Indianapolis, IN 46250. Terminated |
JJY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.