510(k) K151395
- Device
- Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets
- Applicant
- Immunalysis Corporation
- 510(k) number
- K151395
- Product code
- DJR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-07-24
- Date received
- 2015-05-26
- Regulation
- 862.3620
- Classification name
- Enzyme Immunoassay, Methadone
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Joseph Ginete
- Address
- 829 Towne Center Dr. Pomona CA US 91767 91767
FDA Registration Numbers#
- 3010934853
- 3031697086
- 3009238284
- 2030861
- 3006198300
- 3030413233
- 2060833
- 3030648160
- 3010825766
- 2020952
- 3009585529
- 3010800486
- 3013679502
- 2246703
- 1910144
- 3006048451
- 3003917514
- 3009212837
- 2050010
- 3005641941
- 2030633
- 3011522054
- 3005174594
- 3004987297
- 3004175381
- 1649661
- 3000308930
- 3008987086
- 2027969
- 2031229
- 3013684380
- 3013982035
- 1220972
- 2029372
- 3003795116
- 3036649420
- 3021186226
- 1832216
- 3010220539
- 3034694973
- 3003610499
- 2432235
- 3010939897
- 3027519599
- 3005333358
- 3004493545
- 3011559327
- 3002642396
- 8043323
- 3008517993
- 3012073813
- 3005360469
- 3005755244
- 9614673
- 3012963943
- 2250051
- 2050012
- 2915274
- 3009473156
- 9610529
- 3014607865
- 3043127647
- 3008416529
- 2517506
- 3007838093
- 3023296261
- 2025099
- 1319808
- 3005345870
- 9610126
- 2090110
- 3016609999
- 2087033
- 3007126977
- 1827821
- 3024463179
- 3005984081
- 1063851
- 1050155
- 2032364
Source Documents#
Other 510(k) Records For Product Code DJR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K192433 | LZI Methadone II Enzyme Immunoassay | Lin-Zhi International, Inc. | 2019-10-04 |
| K182779 | ARK EDDP Assay | Ark Diagnostics, Inc. | 2018-11-21 |
| K170416 | LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators | Lin-Zhi International, Inc. | 2017-06-26 |
| K160793 | 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. | 2016-08-17 |
| K152025 | AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) | Assure Tech. Co., Ltd. | 2015-10-05 |
| K151441 | First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test | W.H.P.M., Inc. | 2015-06-29 |
| K131232 | WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100) | Guangzhou Wondfo Biotech Co., Ltd. | 2013-05-31 |
| K092272 | RANDOX METHADONE ASSAY | Randox Laboratories, Ltd. | 2010-11-18 |
| K092258 | RANDOX METABOLITE (EDDP) ASSAY | Randox Laboratories, Ltd. | 2010-11-09 |
| K092048 | ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP | Biosite Incorporated | 2010-04-19 |
| K081378 | DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS | Thermo Fisher Scientific | 2009-01-14 |
| K062637 | VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT PERFORMANCE, VERIFIERS I, II, III, IV & V | Ortho-Clinical Diagnostics, Inc. | 2006-11-22 |
| K060791 | TRIAGE TOX DRUG SCREEN, MODEL 94400 | Biosite Incorporated | 2006-06-22 |
| K052197 | FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST | W.H.P.M., Inc. | 2006-06-09 |
| K051058 | METHADONE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS | Lin-Zhi International, Inc. | 2006-03-29 |
Legacy Summary#
summary
FDA Review#
Decision Summary