Randox Phenytoin
FDA 510(k) K011393 · Randox Laboratories, Ltd.
510(k) numberK011393
Submission
- Device name
- Randox Phenytoin
- Applicant
- Randox Laboratories, Ltd.
Crumlin, Co. Antrim, IE - Received
- May 7, 2001
- Decision date
- December 4, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DIP – Enzyme Immunoassay, Diphenylhydantoin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3350
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DIP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K080696 | Architect Iphenytoin Reagents and Architech Iphenytoin Calibrators with Models 1P34, and…DIP · Traditional | Abbott Laboratories | 09/11/2008SE |
| K063145 | Phenobarbital, Phenytoin, TDM Calibration Set B and Abtrol/Nortrol ControlsDIP · Traditional | Thermo Electron OY | 10/17/2007SE |
| K030428 | Roche Online TDM PhenytoinDIP · Traditional | Roche Diagnostics Corp. | 04/28/2003SE |
| K011347 | Emit 2000 Phenytoin Assay, Model 0SR4A229DIP · Special | Syva Co. | 05/17/2001SE |
| K000006 | Immulite Phenytoin, Immulite 2000 Phenytoin, Catalog # LKPN1, LKPN5 & L2KPN2, L2KPN6DIP · Traditional | Diagnostic Products Corp. | 02/28/2000SE |
| K993026 | Abbot Aeroset Phenytoin Assay & Abbot Aeroset Phenytoin CalibratorsDIP · Traditional | Syva Co. | 01/27/2000SE |
| K973414 | Ace Phenytoin Reagent, AED CalibratorsDIP · Traditional | Schiapparelli Biosystems, Inc. | 11/04/1997SE |
| K963840 | Cedia Phenytoin II AssayDIP · Traditional | Boehringer Mannheim Corp. | 11/20/1996SE |
| K943980 | Il Test Phenytion CalibratorsDIP · Traditional | Instrumentation Laboratory CO | 05/01/1995SE |
| K945725 | Phenytion Eia TestDIP · Traditional | Diagnostic Reagents, Inc. | 02/03/1995SE |
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| 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 |
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Questions and answers
When was Randox Phenytoin cleared by the FDA?
Randox Phenytoin (K011393) received a 510(k) decision of Substantially Equivalent on December 4, 2001, 211 days after the submission was received.
What is the product code of K011393?
The FDA product code is DIP – Enzyme Immunoassay, Diphenylhydantoin, a Class II (moderate risk) device regulated under 21 CFR 862.3350.