510(k) K070929
K070929 is an FDA 510(k) premarket notification submitted by ACON Laboratories, Inc. for the device "ACON U120 URINE ANALYZER, MODEL U111-101". The FDA issued a decision of Substantially Equivalent on July 30, 2007. The device falls under product code KQO (Automated Urinalysis System), a Class I device regulated under 21 CFR 862.2900. ACON Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 30, 2007
- Date Received
- April 3, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Automated Urinalysis System
- Device Class
- Class I
- Regulation Number
- 862.2900
- Review Panel
- CH
- Submission Type