Home / 510(k) Clearances / K171695

510(k) K171695

First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of Abuse Dip Card Test Marijuana, First Sign Drug of Abuse Cup Test Marijuana by W.H.P.M., Inc. — Product Code NFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2018
Date Received
June 7, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Amphetamine, Over The Counter
Device Class
Class II
Regulation Number
862.3100
Review Panel
TX
Submission Type

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  • K152551 — First Sign® Drug of Abuse Buprenorphine Cup Test, First Sign® Drug of Abuse Bupr (November 9, 2015)
  • K151441 — First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test (June 29, 2015)
  • K150162 — First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test (February 26, 2015)
  • K142353 — First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test (October 7, 2014)
  • K052197 — FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST (June 9, 2006)
  • K051841 — WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST (August 22, 2005)
  • K041202 — HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST (August 12, 2004)

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