First Sign® - DOA 12 in 1 Test Cup W/ AD, 25Pcs/Box; First Sign for Hemosure, CLIA Waived AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/THC/CR-SG-OX
2024-10-16
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3009388488 | 3009388488 | HEMOSURE, INC. | 1 | Y | 2020-04-25 | 5358 Irwindale Avenue Irwindale CA US 91706 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 191738 | 1265742567 | K152551 | 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 Sign® Drug of Abuse Morphine Dip Card Test. | DJG | 2015-11-09 |
| 191738 | 1031329026 | K151441 | First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test | DJR | 2015-06-29 |
| 191738 | 1071436437 | K150162 | First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test | LAF | 2015-02-26 |
| 191738 | 1697530739 | K142353 | First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test | DIO | 2014-10-07 |
| 191738 | 1421448046 | K052197 | FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST | DJR | 2006-06-09 |
| 191738 | 1136004477 | K051841 | WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST | JHI | 2005-08-22 |
| 191738 | 1813210905 | K041273 | ONE-STEP PREGNANCY TEST | LCX | 2004-05-20 |
| 191738 | 1977517878 | K041202 | HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST | KHE | 2004-08-12 |
| 191738 | 1795054258 | K032575 | FIRST SIGN DRUG OF ABUSE SCREENING TEST | DKZ | 2004-05-19 |
| 191738 | 1450257519 | K012284 | WH ACCU TEST PREGNANCY TEST | JHI | 2001-08-28 |
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