Emit II Plus Methadone Assay, Model OSRE229
FDA 510(k) K010962 · Syva Co., Dade Behring, Inc.
510(k) numberK010962
Submission
- Device name
- Emit II Plus Methadone Assay, Model OSRE229
- Applicant
- Syva Co., Dade Behring, Inc.
San Jose, CA, US - Received
- March 30, 2001
- Decision date
- April 26, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DJR – Enzyme Immunoassay, Methadone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3620
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DJR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K192433 | LZI Methadone II Enzyme ImmunoassayDJR · Traditional | Lin-Zhi International, Inc. | 10/04/2019SE |
| K182779 | ARK EDDP AssayDJR · Traditional | Ark Diagnostics, Inc. | 11/21/2018SE |
| K170416 | LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300)…DJR · Traditional | Lin-Zhi International, Inc. | 06/26/2017SE |
| K160793 | First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of…DJR · Traditional | W.H.P.M., Inc. | 08/17/2016SE |
| K152025 | AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)…DJR · Traditional | Assure Tech. Co., Ltd. | 10/05/2015SE |
| K151395 | Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators…DJR · Traditional | Immunalysis Corporation | 07/24/2015SE |
| K151441 | First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup TestDJR · Traditional | W.H.P.M., Inc. | 06/29/2015SE |
| K131232 | Wondfo Methadone Urine Test (MTD 200), Wondofo Morphine Urine Test (Mop 100)DJR · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 05/31/2013SE |
| K092272 | Randox Methadone AssayDJR · Traditional | Randox Laboratories, Ltd. | 11/18/2010SE |
| K092258 | Randox Metabolite (Eddp) AssayDJR · Traditional | Randox Laboratories, Ltd. | 11/09/2010SE |
More from Randox Laboratories, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K011920 | Emit 2000 Digoxin Assay, Model OSR4H229KXT · Special | 07/02/2001SE |
| K011620 | Emit 2000 N-Acetylprocainamide Assay, Model OSR4N229LAN · Special | 06/18/2001SE |
| K011605 | Emit 2000 Quinidine Assay, Model OSR4Q229LBZ · Special | 06/12/2001SE |
| K011300 | Emit II Plus Cannabinoid Assay, Model OSR9N229LDJ · Special | 05/17/2001SE |
| K011306 | Emit II Plus Benzodiazepine Assay, Model 0SR9F229JXM · Special | 05/16/2001SE |
| K011289 | Emit II Plus Opiate Assay, Model OSR9B229DJG · Special | 05/15/2001SE |
| K011161 | Modification to the Emit II Plus Phencyclidine Assay, Model OSR9J229LCM · Special | 05/15/2001SE |
| K011166 | Modification to Emit 2000 Theophylline Assay, Model Osr 4P229KLS · Special | 05/10/2001SE |
| K011164 | Modification to the Emit II Plus Methaqualone Assay, Model OSR9Q229KXS · Special | 05/10/2001SE |
| K011163 | Modification to the Emit II Plus Propoxyphene Assay, Model OSR9G229JXN · Special | 05/10/2001SE |
Questions and answers
When was Emit II Plus Methadone Assay, Model OSRE229 cleared by the FDA?
Emit II Plus Methadone Assay, Model OSRE229 (K010962) received a 510(k) decision of Substantially Equivalent on April 26, 2001, 27 days after the submission was received.
What is the product code of K010962?
The FDA product code is DJR – Enzyme Immunoassay, Methadone, a Class II (moderate risk) device regulated under 21 CFR 862.3620.