510(k) K060280
K060280 is an FDA 510(k) premarket notification submitted by Iris International, Inc. for the device "ICHEM 100 URINE CHEMISTRY ANALYZER". The FDA issued a decision of Substantially Equivalent on June 13, 2006. The device falls under product code JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative)), a Class II device regulated under 21 CFR 862.1340. Iris International, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 13, 2006
- Date Received
- February 2, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
- Device Class
- Class II
- Regulation Number
- 862.1340
- Review Panel
- CH
- Submission Type