Atlas FDA

Atellica® CH Diazo Direct Bilirubin (D_DBil)

FDA 510(k) clearance K223078 · decided 2023-06-12

Clearance details

K-number
K223078
Device name
Atellica® CH Diazo Direct Bilirubin (D_DBil)
Applicant
Siemens Healthcare Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2022-09-30
Decision date
2023-06-12
Days to decision
255 days
Clearance type
Traditional
Product code
CIG
Device class
2
Regulation number
862.1110
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Newark, DE, 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 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
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

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Atellica IM Total PSA II (tPSAII) (P240021)Siemens Healthcare Diagnostics, Inc.2025-12-03
IMMULITE 2000 PSA (P930027/S037)Siemens Healthcare Diagnostics, Inc.2025-10-30
IMMULITE 2000 AFP (P010007/S024)Siemens Healthcare Diagnostics, Inc.2025-10-30
Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2) (P100039/S018)Siemens Healthcare Diagnostics, Inc.2025-10-17
Atellica IM Anti-HBe2 (aHBe2) (P200017/S005)Siemens Healthcare Diagnostics, Inc.2025-10-17
Atellica IM HBc Total 2 (HBcT2) (P210019/S004)Siemens Healthcare Diagnostics, Inc.2025-10-17
IMMULITE 2000 Prostate-Specific Antigen (PSA) (P930027/S036)Siemens Healthcare Diagnostics, Inc.2025-08-14
ADVIA Centaur® AFP Immunoassay; Atellica IM Alpha Fetoprotein (AFP) (P930036/S025)Siemens Healthcare Diagnostics, Inc.2025-07-16