510(k) K853140
K853140 is an FDA 510(k) premarket notification submitted by Medical Diagnostics, Ca. for the device "MDI QUIK TEST NARCOTICS DRUG SCREEN". The FDA issued a decision of Substantially Equivalent on March 3, 1986. The device falls under product code DNK (Thin Layer Chromatography, Morphine), a Class II device regulated under 21 CFR 862.3640. Medical Diagnostics, Ca. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 3, 1986
- Date Received
- July 29, 1985
- 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