510(k) K061559
K061559 is an FDA 510(k) premarket notification submitted by Acon Laboratories Co. for the device "ACON URINALYSIS REAGENT STRIPS". The FDA issued a decision of Substantially Equivalent on August 11, 2006. The device falls under product code CDM (Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)), a Class I device regulated under 21 CFR 862.1785. Acon Laboratories Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 11, 2006
- Date Received
- June 5, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
- Device Class
- Class I
- Regulation Number
- 862.1785
- Review Panel
- CH
- Submission Type