Atlas FDA

Citryte

FDA 510(k) clearance K171015 · decided 2017-10-13

Clearance details

K-number
K171015
Device name
Citryte
Applicant
Di-Chem, Inc.
Decision
Substantially Equivalent
Date received
2017-04-04
Decision date
2017-10-13
Days to decision
192 days
Clearance type
Traditional
Product code
KPO
Device class
2
Regulation number
876.5820
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Champlin, MN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.