510(k) K063390
K063390 is an FDA 510(k) premarket notification submitted by Ind Diagnostic, Inc. for the device "URINE CHEMISTRY ANALYZER UR-50". The FDA issued a decision of Substantially Equivalent on March 1, 2007. The device falls under product code JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative)), a Class II device regulated under 21 CFR 862.1340. Ind Diagnostic, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 1, 2007
- Date Received
- November 9, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
- Device Class
- Class II
- Regulation Number
- 862.1340
- Review Panel
- CH
- Submission Type