510(k) K933480
K933480 is an FDA 510(k) premarket notification submitted by Drug Screening Systems, Inc. for the device "MICROLINE SCREEN FOR BARBITURATES". The FDA issued a decision of Substantially Equivalent on October 29, 1993. The device falls under product code DIS (Enzyme Immunoassay, Barbiturate), a Class II device regulated under 21 CFR 862.3150. Drug Screening Systems, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 29, 1993
- Date Received
- July 15, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Barbiturate
- Device Class
- Class II
- Regulation Number
- 862.3150
- Review Panel
- TX
- Submission Type