510(k) K182384
K182384 is an FDA 510(k) premarket notification submitted by Healthy.Io, Ltd. for the device "ACR LAB Urine Analysis Test System". The FDA issued a decision of Substantially Equivalent on July 26, 2019. The device falls under product code JFY (Enzymatic Method, Creatinine), a Class II device regulated under 21 CFR 862.1225. Healthy.Io, Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 26, 2019
- Date Received
- August 31, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzymatic Method, Creatinine
- Device Class
- Class II
- Regulation Number
- 862.1225
- Review Panel
- CH
- Submission Type