510(k) K910525
K910525 is an FDA 510(k) premarket notification submitted by Drug Screening Systems, Inc. for the device "MICROLINE SCREEN FOR METHAMPHETAMINE". The FDA issued a decision of Substantially Equivalent on April 5, 1991. The device falls under product code DIT (Thin Layer Chromatography, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Drug Screening Systems, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 5, 1991
- Date Received
- February 7, 1991
- 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