FDA 510(k) Applications Submitted by W.H.P.M., Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K041202 05/07/2004 HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST W.H.P.M., INC.
K041273 05/12/2004 ONE-STEP PREGNANCY TEST W.H.P.M., INC.
K051841 07/07/2005 WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST W.H.P.M., INC.
K012284 07/20/2001 WH ACCU TEST PREGNANCY TEST W.H.P.M., INC.
K052197 08/12/2005 FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST W.H.P.M., INC.
K032575 08/20/2003 FIRST SIGN DRUG OF ABUSE SCREENING TEST W.H.P.M., INC.
K160793 03/23/2016 First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline) W.H.P.M., INC.
K150162 01/26/2015 First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test W.H.P.M., Inc.
K210327 02/04/2021 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 W.H.P.M., Inc.
K151441 05/29/2015 First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test W.H.P.M., INC.
K171695 06/07/2017 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 W.H.P.M., Inc.
K142353 08/21/2014 First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test W.H.P.M., Inc.
K152551 09/08/2015 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, First W.H.P.M., INC.


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