Phenytion Eia Test
FDA 510(k) K945725 · Diagnostic Reagents, Inc.
510(k) numberK945725
Submission
- Device name
- Phenytion Eia Test
- Applicant
- Diagnostic Reagents, Inc.
Mountain View, CA, US - Received
- November 22, 1994
- Decision date
- February 3, 1995
- 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 |
| K011393 | Randox PhenytoinDIP · Traditional | Randox Laboratories, Ltd. | 12/04/2001SE |
| 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 |
More from Instrumentation Laboratory CO
| 510(k) | Device | Decision |
|---|---|---|
| K983268 | Modification of Tricyclic Serum Tox Eia AssayLFH · Traditional | 11/18/1998SE |
| K983812 | Napa Eia AssayLAN · Traditional | 11/16/1998SE |
| K983323 | Digoxin ImmunoassayKXT · Traditional | 11/12/1998SE |
| K983280 | Vancomycin Eia AssayLEH · Traditional | 11/06/1998SE |
| K983159 | Drugs of Abuse Urine Calibrators and ControlsDKB · Traditional | 11/05/1998SE |
| K973102 | Lidocaine Eia AssayKLR · Traditional | 09/12/1997SE |
| K972835 | 50NG/ML Cocaine Metabolite CalibratorDLJ · Traditional | 08/28/1997SE |
| K972526 | Methadone Eia AssayDJR · Traditional | 08/04/1997SE |
| K964212 | Quinidine Enzyme ImmunoassayLBZ · Traditional | 12/18/1996SE |
| K963835 | Digoxin Enzyme ImmunoassayKXT · Traditional | 12/10/1996SE |
Questions and answers
When was Phenytion Eia Test cleared by the FDA?
Phenytion Eia Test (K945725) received a 510(k) decision of Substantially Equivalent on February 3, 1995, 73 days after the submission was received.
What is the product code of K945725?
The FDA product code is DIP – Enzyme Immunoassay, Diphenylhydantoin, a Class II (moderate risk) device regulated under 21 CFR 862.3350.