510(k) K790805
K790805 is an FDA 510(k) premarket notification submitted by Technical Resources, Inc. for the device "DRUG ABUSE DIPSTICKS". The FDA issued a decision of Substantially Equivalent on June 6, 1979. The device falls under product code DIT (Thin Layer Chromatography, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Technical Resources, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 6, 1979
- Date Received
- April 25, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Thin Layer Chromatography, Amphetamine
- Device Class
- Class II
- Regulation Number
- 862.3100
- Review Panel
- TX
- Submission Type