Atlas FDA

BAYER ADVIA IMS SYSTEM

FDA 510(k) clearance K993867 · decided 2000-04-10

Clearance details

K-number
K993867
Device name
BAYER ADVIA IMS SYSTEM
Applicant
Bayer Corp.
Decision
Substantially Equivalent
Date received
1999-11-15
Decision date
2000-04-10
Days to decision
147 days
Clearance type
Traditional
Product code
CIG
Device class
2
Regulation number
862.1110
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Tarrytown, NY, US
Third-party review
No
Expedited review
No

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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
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Recalls involving this device

No recalls on record reference this clearance.