Atlas FDA

COBAS C 111 ANALYZER

FDA 510(k) clearance K071211 · decided 2007-07-30

Clearance details

K-number
K071211
Device name
COBAS C 111 ANALYZER
Applicant
Roche Diagnostics
Decision
Substantially Equivalent
Date received
2007-05-01
Decision date
2007-07-30
Days to decision
90 days
Clearance type
Traditional
Product code
CIT
Device class
2
Regulation number
862.1100
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Indianapolis, IN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for clinical use Pro recall (Z-0387-2017)Roche Diagnostics Operations, Inc.2016-11-10
Roche Cobas c 111 Analyzer The Roche Cobas c 111 analyzer is an in-vitro diagnostic analyz recall (Z-0311-2012)Roche Diagnostics Operations, Inc.2011-11-30
Roche COBAS c 111 Analyzer with ISE module option, GMMI No. 04777433001; Roche Diagnostics recall (Z-1009-2009)Roche Diagnostics Corp.2009-03-24

PMA approvals by this applicant

RecordFirmDate
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S010)Roche Diagnostics2025-05-22
Elecsys Anti-HBe (P190005/S007)Roche Diagnostics2025-05-22
Elecsys Anti-HBe (P190005/S006)Roche Diagnostics2024-10-03
Elecsys Anti-HBs / Elecsys HBs II (P190034/S009)Roche Diagnostics2024-10-03
Elecsys Anti-HBs II (P190034/S008)Roche Diagnostics2024-08-29
Elecsys Anti-HBe (P190005/S005)Roche Diagnostics2024-08-29
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S007)Roche Diagnostics2024-07-23
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S005)Roche Diagnostics2024-05-01