510(k) K080347
K080347 is an FDA 510(k) premarket notification submitted by Taiwan Unison Biotech, Inc. for the device "UNISCAN -DOA SYSTEM". The FDA issued a decision of Substantially Equivalent on October 9, 2008. The device falls under product code DJC (Thin Layer Chromatography, Methamphetamine), a Class II device regulated under 21 CFR 862.3610.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 9, 2008
- Date Received
- February 8, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Thin Layer Chromatography, Methamphetamine
- Device Class
- Class II
- Regulation Number
- 862.3610
- Review Panel
- TX
- Submission Type