Atlas FDA

COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226

FDA 510(k) clearance K063543 · decided 2006-12-22

Clearance details

K-number
K063543
Device name
COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226
Applicant
Roche Diagnostics Corp.
Decision
Substantially Equivalent
Date received
2006-11-24
Decision date
2006-12-22
Days to decision
28 days
Clearance type
Special
Product code
CIG
Device class
2
Regulation number
862.1110
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Indianapolis, IN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Atellica CH Diazo Total Bilirubin (D_TBil) (K251998)Siemens Healthcare Diagnostics, Inc.2026-02-27
Atellica® CH Diazo Direct Bilirubin (D_DBil) (K223078)Siemens Healthcare Diagnostics, Inc.2023-06-12
Atellica® CH Diazo Total Bilirubin (D_TBil) (K222104)Siemens Healthcare Diagnostics, Inc.2023-03-20
Total Bilirubin2 (K223324)Abbott Ireland Diagnostics Division2022-12-29
VITROS XT Chemistry Products TBIL-ALKP Slides (K190807)Ortho-Clinical Diagnostics, Inc.2019-04-26
ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1 (K171401)Elitechgroup2017-07-11
Total Bilirubin (K150510)Abbott Laboratories2015-04-02
COBAS C BILIRUBIN TOTAL GEN.3 (K131544)Roche Diagnostics2013-07-17
S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN (K131217)Hitachi Chemical Diagnostics, Inc.2013-06-07
EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT (K123802)Medica Corp.2013-03-01
COBAS INTEGRA BILIRUBIN DIRECT GEN.2 (K123965)Roche Diagnostics2013-02-28
ARCHITECT TOTAL BILIRUBIN (K121985)Abbott Laboratories2013-02-01

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET (P990056/S046)Roche Diagnostics Corp.2026-04-29
ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK (P000027/S045)Roche Diagnostics Corp.2026-04-29
Elecsys total PSA assay (P990056/S045)Roche Diagnostics Corp.2026-02-27
Elecsys free PSA assay (P000027/S044)Roche Diagnostics Corp.2026-02-27
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