Auto-Lyte Methadone Dia
FDA 510(k) K944056 · Solarcare Technologies Corp,Inc.
510(k) numberK944056
Submission
- Device name
- Auto-Lyte Methadone Dia
- Applicant
- Solarcare Technologies Corp,Inc.
Bethlehem, PA, US - Received
- August 19, 1994
- Decision date
- December 29, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K954326 | STC Diagnostics Auto-Lyte Urinary Hemoglobin AssayJIT · Traditional | 07/23/1996SE |
| K954156 | STC Diagnostics Auto-Lyte Urinary Leukocyte Esterase AssayKQO · Traditional | 07/22/1996SE |
| K955905 | STC Diagnostics Auto-Lyte Urinary Protein AssayCEK · Traditional | 05/30/1996SE |
| K954158 | STC Diagnostics Auto-Lyte PH AssayKQO · Traditional | 04/30/1996SE |
| K940048 | STC Diagnostics PCP Micro-Plate Eia ModificationDLJ · Traditional | 03/19/1996SE |
| K954073 | STC Diagnostics LSD Micro-Plate EiaDLB · Traditional | 11/29/1995SE |
| K954266 | STC Diagnostics Auto-Lyte Creatinine AssayCGX · Traditional | 10/13/1995SE |
| K935573 | Amphetamines Micro-Plate EiaDKZ · Traditional | 07/14/1995SE |
| K935565 | Opiates Micro-Plate AssayDJG · Traditional | 07/14/1995SE |
| K950308 | STC Diagnostics Auto-Lyte(R) Methaqualone EiaJXS · Traditional | 04/14/1995SE |
Questions and answers
When was Auto-Lyte Methadone Dia cleared by the FDA?
Auto-Lyte Methadone Dia (K944056) received a 510(k) decision of Substantially Equivalent on December 29, 1994, 132 days after the submission was received.
What is the product code of K944056?
The FDA product code is DJR – Enzyme Immunoassay, Methadone, a Class II (moderate risk) device regulated under 21 CFR 862.3620.