Atlas FDA

ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770

FDA 510(k) clearance K093732 · decided 2010-03-22

Clearance details

K-number
K093732
Device name
ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770
Applicant
Siemens Healthcare Diagnostics
Decision
Substantially Equivalent
Date received
2009-12-04
Decision date
2010-03-22
Days to decision
108 days
Clearance type
Abbreviated
Product code
JIX
Device class
2
Regulation number
862.1150
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Tarrytown, NY, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
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