510(k) K990325

QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICE by Syntron Bioresearch, Inc. — Product Code DKZ

K990325 is an FDA 510(k) premarket notification submitted by Syntron Bioresearch, Inc. for the device "QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICE". The FDA issued a decision of Substantially Equivalent on June 24, 1999. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Syntron Bioresearch, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1999
Date Received
February 2, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Amphetamine
Device Class
Class II
Regulation Number
862.3100
Review Panel
TX
Submission Type