Atlas FDA

UB ANALYZER UA-2, REAGENT KIT AND BILIRUBIN CONTROL

FDA 510(k) clearance K972382 · decided 1998-09-14

Clearance details

K-number
K972382
Device name
UB ANALYZER UA-2, REAGENT KIT AND BILIRUBIN CONTROL
Applicant
Arrows Co., Ltd.
Decision
Substantially Equivalent
Date received
1997-06-26
Decision date
1998-09-14
Days to decision
445 days
Clearance type
Traditional
Product code
CIG
Device class
2
Regulation number
862.1110
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Osaka, JP
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
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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.