510(k) K120124
K120124 is an FDA 510(k) premarket notification submitted by ACON Laboratories, Inc. for the device "FORESIGHT U120 URINE ANALYZER". The FDA issued a decision of Substantially Equivalent on March 6, 2012. The device falls under product code JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative)), a Class II device regulated under 21 CFR 862.1340. ACON Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 6, 2012
- Date Received
- January 17, 2012
- Clearance Type
- Special
- 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