Atlas FDA

COBAS C BILIRUBIN TOTAL GEN.3

FDA 510(k) clearance K131544 · decided 2013-07-17

Clearance details

K-number
K131544
Device name
COBAS C BILIRUBIN TOTAL GEN.3
Applicant
Roche Diagnostics
Decision
Substantially Equivalent
Date received
2013-05-29
Decision date
2013-07-17
Days to decision
49 days
Clearance type
Traditional
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

+ Add to Predicate Builder ◉ Watch Roche Diagnostics

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

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
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
ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II (K110780)Elitechgroup2011-10-07

Recalls involving this device

RecordFirmDate
Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: In vitro test f recall (Z-0153-2020)Roche Diagnostics Operations, Inc.2019-10-16
Bilirubin Total Gen.3, Cat. Nos. 05795397190, 05795419190, 05795320160, 05795338160, 05795 recall (Z-1145-2019)Roche Diagnostics Corporation2019-04-13

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