Atlas FDA

VANTERA CLINICAL ANALYZER

FDA 510(k) clearance K133849 · decided 2014-10-22

Clearance details

K-number
K133849
Device name
VANTERA CLINICAL ANALYZER
Applicant
Liposcience
Decision
Substantially Equivalent
Date received
2013-12-19
Decision date
2014-10-22
Days to decision
307 days
Clearance type
Special
Product code
NSU
Device class
2
Regulation number
862.2570
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Raleigh, NC, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.