Atlas FDA

COBAS 8000 MODULAR SERIES ANALYZER

FDA 510(k) clearance K100853 · decided 2010-09-09

Clearance details

K-number
K100853
Device name
COBAS 8000 MODULAR SERIES ANALYZER
Applicant
Roche Diagnostics Corp.
Decision
Substantially Equivalent
Date received
2010-03-26
Decision date
2010-09-09
Days to decision
167 days
Clearance type
Special
Product code
DCF
Device class
2
Regulation number
866.5040
Medical specialty
Immunology
Advisory committee
Immunology
Location
Indianapolis, IN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Brand Name: cobas c 6000 MODULAR Series System e 601 cobas c 8000 MODULAR Series System - recall (Z-0378-2018)Roche Diagnostics Corporation2018-01-16
Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical chemist recall (Z-1449-2014)Roche Diagnostics Operations, Inc.2014-04-10
Cobas 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the co recall (Z-1368-2013)Roche Diagnostics Operations, Inc.2013-05-23

PMA approvals by this applicant

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ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK (P000027/S043)Roche Diagnostics Corp.2025-05-27
ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET (P990056/S044)Roche Diagnostics Corp.2025-05-27
Elecsys Anti-HBc II (P100031/S033)Roche Diagnostics Corp.2025-05-22
Elecsys Anti-HBc II (P100032/S023)Roche Diagnostics Corp.2025-05-22
Elecsys Anti-HBc IgM (P110031/S027)Roche Diagnostics Corp.2025-05-22
Elecsys Anti-HBc IgM (P110022/S034)Roche Diagnostics Corp.2025-05-22
Elecsys Anti-HBs (P010054/S048)Roche Diagnostics Corp.2025-05-22
Elecsys Anti-HBc IgM and PreciControl Anti-HBc IgM (P110031/S025)Roche Diagnostics Corp.2024-11-22