510(k) K945829
K945829 is an FDA 510(k) premarket notification submitted by Drug Screening Systems, Inc. for the device "MICROLINE SCREEN FOR BENZODIAZEPINE". The FDA issued a decision of Substantially Equivalent on January 25, 1995. The device falls under product code JXM (Enzyme Immunoassay, Benzodiazepine), a Class II device regulated under 21 CFR 862.3170. Drug Screening Systems, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 25, 1995
- Date Received
- November 29, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Benzodiazepine
- Device Class
- Class II
- Regulation Number
- 862.3170
- Review Panel
- TX
- Submission Type