Atlas FDA

CITRISOL ACID CONCENTRATE

FDA 510(k) clearance K130511 · decided 2014-02-10

Clearance details

K-number
K130511
Device name
CITRISOL ACID CONCENTRATE
Applicant
Diasol, Inc.
Decision
Substantially Equivalent
Date received
2013-02-27
Decision date
2014-02-10
Days to decision
348 days
Clearance type
Traditional
Product code
KPO
Device class
2
Regulation number
876.5820
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
San Fernando, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.