Il Test Phenytoin
FDA 510(k) K860286 · Allied Instrumentation Laboratory
510(k) numberK860286
Submission
- Device name
- Il Test Phenytoin
- Applicant
- Allied Instrumentation Laboratory
Lexington, MA, US - Received
- January 28, 1986
- Decision date
- March 5, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K861901 | MULTI-4 Co-Oximeter ControlJJY · Traditional | 06/17/1986SE |
| K860365 | Phenobarbital Test SystemDLZ · Traditional | 03/17/1986SE |
| K853858 | Il Test Theophylline AssayKLS · Traditional | 10/15/1985SE |
| K852676 | Il System 1304 & 1306, Ph/Blood Gas AnalyzersCHL · Traditional | 07/22/1985SE |
| K851933 | Clinical Chemistry Analytical SystemJJF · Traditional | 06/10/1985SE |
| K850748 | I-L Test, Direct Bilirubin SetCIG · Traditional | 04/03/1985SE |
Questions and answers
When was Il Test Phenytoin cleared by the FDA?
Il Test Phenytoin (K860286) received a 510(k) decision of Substantially Equivalent on March 5, 1986, 36 days after the submission was received.
What is the product code of K860286?
The FDA product code is DIP – Enzyme Immunoassay, Diphenylhydantoin, a Class II (moderate risk) device regulated under 21 CFR 862.3350.