Atlas FDA

ARIOL

FDA 510(k) clearance K033200 · decided 2004-03-18

Clearance details

K-number
K033200
Device name
ARIOL
Applicant
Applied Imaging Corp.
Decision
Substantially Equivalent
Date received
2003-10-02
Decision date
2004-03-18
Days to decision
168 days
Clearance type
Traditional
Product code
NQN
Device class
2
Regulation number
864.1860
Medical specialty
Hematology
Advisory committee
Hematology
Location
Santa Clara, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.