Atlas FDA

BILIRUBIN, DINGLE VALVE DPD

FDA 510(k) clearance K781921 · decided 1979-01-03

Clearance details

K-number
K781921
Device name
BILIRUBIN, DINGLE VALVE DPD
Applicant
Boehringer Mannheim Corp.
Decision
Substantially Equivalent
Date received
1978-11-13
Decision date
1979-01-03
Days to decision
51 days
Clearance type
Traditional
Product code
CIG
Device class
2
Regulation number
862.1110
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Mchenry, IL, 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
ENZYMUN TEST{R} CEA (P860058/S001)Boehringer Mannheim Corp.1993-07-29
ENZYMUN-TEST{R} AFP (P860044/S003)Boehringer Mannheim Corp.1991-09-03
ENZYMUN-TEST{R} AFP (P860044/S002)Boehringer Mannheim Corp.1991-07-19
ENZYMUN-TEST{R} AFP (P860044/S001)Boehringer Mannheim Corp.1990-08-03
MICUR-MIC SYSTEMS (P820073)Boehringer Mannheim Corp.1983-06-29