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FDA 510(k) & PMA Approved Devices — 10 products

Total Devices10
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K200754 Hemosure Accu-Reader A100OOX2022-06-02 View
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 CupQBF2021-08-12 View
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 MarijuanaNFT2018-02-05 View
510(k) K160793 First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline)DJR2016-08-17 View
510(k) K052197 FIRST SIGN DRUG OF ABUSE URINE SCREENING TESTDJR2006-06-09 View
510(k) K051841 WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TESTJHI2005-08-22 View
510(k) K041202 HEMOSURE ONE-STEP FECAL OCCULT BLOOD TESTKHE2004-08-12 View
510(k) K041273 ONE-STEP PREGNANCY TESTLCX2004-05-20 View
510(k) K032575 FIRST SIGN DRUG OF ABUSE SCREENING TESTDKZ2004-05-19 View
510(k) K012284 WH ACCU TEST PREGNANCY TESTJHI2001-08-28 View
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