510(k) K933480

MICROLINE SCREEN FOR BARBITURATES by Drug Screening Systems, Inc. — Product Code DIS

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