QMS Tm- Phenytoin
FDA 510(k) K904815 · Seradyn, Inc.
510(k) numberK904815
Submission
- Device name
- QMS Tm- Phenytoin
- Applicant
- Seradyn, Inc.
Indianapolis, IN, US - Received
- October 24, 1990
- Decision date
- November 6, 1990
- 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 |
|---|---|---|
| K070645 | Seradyn QMS TopiramateNWM · Traditional | 05/17/2007SE |
| K062966 | QMS Lamotrigine Assay (Reagents), Calibrators & ControlsORH · Traditional | 01/12/2007SE |
| K062204 | Architect Cortisol AssayJFT · Traditional | 09/22/2006SE |
| K060998 | QMS TobramycinLCR · Traditional | 07/21/2006SE |
| K060709 | Multigent GentamicinLCD · Traditional | 06/15/2006SE |
| K052826 | QMS Quinidine. QMS Quinidine CalibratorsLBZ · Traditional | 12/23/2005SE |
| K051211 | QMS Zonisamide Reagents, Calibrators and ControlsNWM · Traditional | 11/18/2005SE |
| K052815 | QMS Amikacin ReagentsKLQ · Traditional | 11/01/2005SE |
| K050419 | QMS VancomycinLEH · Traditional | 04/01/2005SE |
| K042307 | Architect T-Uptake Calibrators (A-F) and Controls (Low, High)JIT · Abbreviated | 11/03/2004SE |
Questions and answers
When was QMS Tm- Phenytoin cleared by the FDA?
QMS Tm- Phenytoin (K904815) received a 510(k) decision of Substantially Equivalent on November 6, 1990, 13 days after the submission was received.
What is the product code of K904815?
The FDA product code is DIP – Enzyme Immunoassay, Diphenylhydantoin, a Class II (moderate risk) device regulated under 21 CFR 862.3350.