Atlas FDA

ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORS

FDA 510(k) clearance K081294 · decided 2008-07-29

Clearance details

K-number
K081294
Device name
ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORS
Applicant
Siemens Healthcare Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2008-05-07
Decision date
2008-07-29
Days to decision
83 days
Clearance type
Traditional
Product code
NQD
Device class
2
Regulation number
866.5270
Medical specialty
Immunology
Advisory committee
Immunology
Location
Tarrytown, NY, US
Third-party review
No
Expedited review
No

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IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP (K063057)Diagnostic Products Corporation2006-12-22
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Recalls involving this device

No recalls on record reference this clearance.

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