510(k) K032575

FIRST SIGN DRUG OF ABUSE SCREENING TEST by W.H.P.M., Inc. — Product Code DKZ

K032575 is an FDA 510(k) premarket notification submitted by W.H.P.M., Inc. for the device "FIRST SIGN DRUG OF ABUSE SCREENING TEST". The FDA issued a decision of Substantially Equivalent on May 19, 2004. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. W.H.P.M., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2004
Date Received
August 20, 2003
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