First Sign® Drug Of Abuse Buprenorphine Cup Test, First Sign® Drug Of Abuse Buprenorphine Dip Card Test, First Sign® Drug Of Abuse Butalbital Cup Test, First Sign® Drug Of Abuse Butalbital Dip Card Test, First Sign® Drug Of Abuse Morphine Cup Test, F

Enzyme Immunoassay, Opiates

W.H.P.M., INC.

The following data is part of a premarket notification filed by W.h.p.m., Inc. with the FDA for First Sign® Drug Of Abuse Buprenorphine Cup Test, First Sign® Drug Of Abuse Buprenorphine Dip Card Test, First Sign® Drug Of Abuse Butalbital Cup Test, First Sign® Drug Of Abuse Butalbital Dip Card Test, First Sign® Drug Of Abuse Morphine Cup Test, F.

Pre-market Notification Details

• Device ID: K152551
• 510k Number: K152551
• Device Name: First Sign® Drug Of Abuse Buprenorphine Cup Test, First Sign® Drug Of Abuse Buprenorphine Dip Card Test, First Sign® Drug Of Abuse Butalbital Cup Test, First Sign® Drug Of Abuse Butalbital Dip Card Test, First Sign® Drug Of Abuse Morphine Cup Test, F
• Classification: Enzyme Immunoassay, Opiates
• Applicant: W.H.P.M., INC. 5358 IRWINDALE AVE. Irwindale, CA 91706
• Contact: John Wan
• Correspondent: Joe Shia; LSI 504E DIAMOND AVE., SUITE I Gaithersburg, MD 20877
• Product Code: DJG
• CFR Regulation Number: 862.3650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-09-08
• Decision Date: 2015-11-09
• Summary: summary