METHADONE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS
FDA 510(k) clearance K051058 · decided 2006-03-29
Clearance details
- K-number
- K051058
- Device name
- METHADONE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS
- Applicant
- Lin-Zhi International, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-04-26
- Decision date
- 2006-03-29
- Days to decision
- 337 days
- Clearance type
- Traditional
- Product code
- DJR
- Device class
- 2
- Regulation number
- 862.3620
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Synnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| LZI Methadone II Enzyme Immunoassay (K192433) | Lin-Zhi International, Inc. | 2019-10-04 |
| ARK EDDP Assay (K182779) | Ark Diagnostics, Inc. | 2018-11-21 |
| LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators (K170416) | Lin-Zhi International, Inc. | 2017-06-26 |
| First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline) (K160793) | W.H.P.M., Inc. | 2016-08-17 |
| AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) (K152025) | Assure Tech. Co., Ltd. | 2015-10-05 |
| Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets (K151395) | Immunalysis Corporation | 2015-07-24 |
| First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test (K151441) | W.H.P.M., Inc. | 2015-06-29 |
| WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100) (K131232) | Guangzhou Wondfo Biotech Co., Ltd. | 2013-05-31 |
| RANDOX METHADONE ASSAY (K092272) | Randox Laboratories, Ltd. | 2010-11-18 |
| RANDOX METABOLITE (EDDP) ASSAY (K092258) | Randox Laboratories, Ltd. | 2010-11-09 |
| ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP (K092048) | Biosite Incorporated | 2010-04-19 |
| DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS (K081378) | Thermo Fisher Scientific | 2009-01-14 |
Recalls involving this device
No recalls on record reference this clearance.