510(k) K890979

TARGET OPIATES-V by V-Tech, Inc. — Product Code DJG

K890979 is an FDA 510(k) premarket notification submitted by V-Tech, Inc. for the device "TARGET OPIATES-V". The FDA issued a decision of Substantially Equivalent on October 4, 1989. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650. V-Tech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1989
Date Received
February 27, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Opiates
Device Class
Class II
Regulation Number
862.3650
Review Panel
TX
Submission Type