510(k) K091287
K091287 is an FDA 510(k) premarket notification submitted by Common Sense , Ltd. for the device "VS-SENSE TEST". The FDA issued a decision of Substantially Equivalent on August 31, 2009. The device falls under product code CEN (Dye-Indicator, Ph (Urinary, Non-Quantitative)), a Class I device regulated under 21 CFR 862.1550. Common Sense , Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 31, 2009
- Date Received
- May 1, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dye-Indicator, Ph (Urinary, Non-Quantitative)
- Device Class
- Class I
- Regulation Number
- 862.1550
- Review Panel
- CH
- Submission Type