510(k) K970579
K970579 is an FDA 510(k) premarket notification submitted by Teco Diagnostics for the device "ONE STEP MORPHINE CARD TEST". The FDA issued a decision of Substantially Equivalent on July 3, 1997. The device falls under product code DNK (Thin Layer Chromatography, Morphine), a Class II device regulated under 21 CFR 862.3640. Teco Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 3, 1997
- Date Received
- February 14, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Thin Layer Chromatography, Morphine
- Device Class
- Class II
- Regulation Number
- 862.3640
- Review Panel
- TX
- Submission Type