Atlas FDA

SENTINEL PLASMAPROTEINS CAL 3X

FDA 510(k) clearance K051457 · decided 2005-07-25

Clearance details

K-number
K051457
Device name
SENTINEL PLASMAPROTEINS CAL 3X
Applicant
Sentinel Ch. Srl
Decision
Substantially Equivalent
Date received
2005-06-02
Decision date
2005-07-25
Days to decision
53 days
Clearance type
Abbreviated
Product code
JIX
Device class
2
Regulation number
862.1150
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Milano, IT
Third-party review
No
Expedited review
No

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Recalls involving this device

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