Atlas FDA

ROCHE DIAGNOSTICS OMNI S ANALYZER

FDA 510(k) clearance K032311 · decided 2003-10-17

Clearance details

K-number
K032311
Device name
ROCHE DIAGNOSTICS OMNI S ANALYZER
Applicant
Roche Diagnostics Corp.
Decision
Substantially Equivalent
Date received
2003-07-28
Decision date
2003-10-17
Days to decision
81 days
Clearance type
Traditional
Product code
CEM
Device class
2
Regulation number
862.1600
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
cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche Di recall (Z-1610-2018)Roche Diagnostics Corporation2018-05-03
Cobas b 221<4>Roche OMNI S4 system; Catalog numbers: 3337138001 and 3337138692 The Roche D recall (Z-1611-2018)Roche Diagnostics Corporation2018-05-03
cobas b 221<6>Roche OMNI S6 system; Catalog numbers: 3337154001 and 3337154692 The Roche D recall (Z-1612-2018)Roche Diagnostics Corporation2018-05-03
cobas b 221 AutoQC Module Complete; Catalog numbers: 3313522001 and 3313522692 The Roche D recall (Z-1613-2018)Roche Diagnostics Corporation2018-05-03
S2 Fluid Pack on the Cobas b 221 system- Catalog Number 03260925184 Blood Gas and Electrol recall (Z-2330-2015)Roche Diagnostics Operations, Inc.2015-08-05
Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer recall (Z-1041-2015)Roche Diagnostics Operations, Inc.2015-02-02
Omni Micro-electrode/reference electrode for cobas b221 analyzer. The Roche Diagnostics Om recall (Z-0064-2015)Roche Diagnostics Operations, Inc.2014-10-10
Omni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Catalog/Part Numbe recall (Z-1315-2014)Roche Diagnostics Operations, Inc.2014-04-02

PMA approvals by this applicant

RecordFirmDate
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