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510(k) K210327

First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, First Sign Multi-Drug Screen Test Cup by W.H.P.M., Inc. — Product Code QBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2021
Date Received
February 4, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Propoxyphene, Over The Counter
Device Class
Class II
Regulation Number
862.3700
Review Panel
TX
Submission Type

The propoxyphene test is an in vitro diagnostic test for the qualitative detection of propoxyphene in human urine. The test is intended for over-the-counter use as the first step in a two step process to provide consumers with information concerning the presence or absence of propoxyphene in a urine sample.

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  • 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)