Randox Methamphetamine Assay
FDA 510(k) K092266 · Randox Laboratories, Ltd.
510(k) numberK092266
Submission
- Device name
- Randox Methamphetamine Assay
- Applicant
- Randox Laboratories, Ltd.
Crumlin, GB - Received
- July 28, 2009
- Decision date
- May 9, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DKB – Calibrators, Drug Mixture
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3200
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DKB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K141928 | Cobas C Acetaminophen GEN.2 Assay, ACET2 CalibratorDKB · Traditional | Roche Diagnostics Operations (Rdo) | 11/25/2014SE |
| K133710 | Lzi Multiple Analyte Set A;B;C Drugs of Abuse ControlsDKB · Traditional | Lin-Zhi International, Inc. | 02/21/2014SE |
| K120936 | Abbott TDM Multiconstituent Calibrator, Thermo Scientific QMS Multi-Constituent…DKB · Abbreviated | Microgenics Corporation | 12/13/2012SE |
| K101752 | Thermo Scientific Cedia Multi-Drug Oft CalibratorsDKB · Traditional | Microgenics Corp. | 04/08/2011SE |
| K090939 | Roche C.F.A.S. Dat Qualitative Plus Clinical Calibrator and Control Set Dat Clinical…DKB · Traditional | Roche Diagnostics | 06/18/2009SE |
| K090900 | Advia Chemistry Drug Calibrator II, Model 10376771DKB · Abbreviated | Siemens Healthcare Diagnostics | 06/01/2009SE |
| K062162 | Dimension Vista System Drugs of Abuse Calibrator (Udat Cal - KC510)DKB · Traditional | Dade Behring, Inc. | 09/14/2006SE |
| K062121 | Dimension Vista System Drug 2 Calibrator (Drug 2 Cal - KC420)DKB · Traditional | Dade Behring, Inc. | 08/25/2006SE |
| K060645 | Preciset Dat Plus I, Preciset Dat Plus II and Cfas Dat Qualitative Plus CalibratorsDKB · Abbreviated | Roche Diagnostics Corp. | 05/30/2006SE |
| K051088 | Multiple Analyte Urine Drugs of Abuse Calibrators and ControlsDKB · Traditional | Lin-Zhi International, Inc. | 06/24/2005SE |
More from Lin-Zhi International, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K250741 | Evidence MultiSTAT DOA Urine MultiPlexDJG · Traditional | 01/23/2026SE |
| K221550 | Evidence MultiSTAT DOA Urine MultiPlexDJG · Traditional | 10/05/2023SE |
| K220451 | Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTATDJG · Traditional | 10/05/2023SE |
| K230890 | ISE ElectrodesCEM · Special | 09/08/2023SE |
| K182042 | Randox Calcium (Ca)CJY · Traditional | 10/23/2018SE |
| K162200 | Randox RX Daytona Plus Magnesium (MG)JGJ · Traditional | 04/28/2017SE |
| K162275 | Randox RX Daytona Plus Alkaline Phosphatase (ALP)CJE · Traditional | 04/21/2017SE |
| K161691 | Direct LDL Cholesterol (LDL)MRR · Traditional | 03/20/2017SE |
| K152085 | Liquid CO2-2 (LCO2-2)KHS · Traditional | 02/24/2016SE |
| K152343 | Direct BilirubinJFM · Traditional | 02/16/2016SE |
Questions and answers
When was Randox Methamphetamine Assay cleared by the FDA?
Randox Methamphetamine Assay (K092266) received a 510(k) decision of Substantially Equivalent on May 9, 2011, 650 days after the submission was received.
What is the product code of K092266?
The FDA product code is DKB – Calibrators, Drug Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.3200.