510(k) K111221
K111221 is an FDA 510(k) premarket notification submitted by ACON Laboratories, Inc. for the device "MISSION U500 URINE ANALYZER". The FDA issued a decision of Substantially Equivalent on January 18, 2012. The device falls under product code JIO (Blood, Occult, Colorimetric, In Urine), a Class II device regulated under 21 CFR 864.6550. ACON Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 18, 2012
- Date Received
- May 2, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Blood, Occult, Colorimetric, In Urine
- Device Class
- Class II
- Regulation Number
- 864.6550
- Review Panel
- HE
- Submission Type