510(k) K100853 ยท DCF Albumin, Antigen, Antiserum, Control
COBAS 8000 MODULAR SERIES ANALYZER
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Sep 9, 2010 |
| Received | Mar 26, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K100853
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 8, 2020 | Roche Diagnostics Operations, Inc. Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use
Open, Classified |
JJE | None listed |
| Jul 18, 2019 | Roche Diagnostics Operations, Inc. Cobas 8000 Modular Analyzer Series:
cobas 8000 ISE module part Numbers : 05964075001
cobas c 701 module part Numbers : 05641489001
cobas c 702 module part Numbers : 06473245001 Terminated |
JJE | None listed |
| Mar 15, 2019 | Roche Diagnostics Corporation cobas e 801 immunoassay analyzer Terminated |
JJE | None listed |
| Apr 3, 2018 | Roche Diagnostics Corporation cobas e 801 immunoassay analyzer, cobas 8000 Modular Series
The device is a fully automated, software controlled analyzer system for in vitro determination of analytes in human body fluids. It is par 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 |
| Jul 28, 2017 | Roche Diagnostics Corporation Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001 Terminated |
JJE | None listed |
| Jul 18, 2017 | Roche Diagnostics Corporation cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module 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 8000 Modular Analyzer Series
c8000, Chemistry (Photometric, Discrete) for clinical use Modular e602: Immunoassay Analyzer
Product Usage:
The VS II system is a stand-alone, computer-controlled i Terminated |
JJE | None listed |
| Apr 10, 2014 | Roche Diagnostics Operations, Inc. Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical chemistry analyzer intended for the in vitro quantitative / qualitative determination of analytes in body fluids. Terminated |
JJE | None listed |
| May 23, 2013 | Roche Diagnostics Operations, Inc. Cobas 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the cobas e 602 module only.
Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantit Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.