Product code DIP
- Device name
- Enzyme Immunoassay, Diphenylhydantoin
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation number
- 862.3350
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K080696 | ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01 | Abbott Laboratories | 2008-09-11 |
| K063145 | PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS | Thermo Electron OY | 2007-10-17 |
| K030428 | ROCHE ONLINE TDM PHENYTOIN | Roche Diagnostics Corp. | 2003-04-28 |
| K011393 | RANDOX PHENYTOIN | Randox Laboratories, Ltd. | 2001-12-04 |
| K011347 | EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229 | Syva Co. | 2001-05-17 |
| K000006 | IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2KPN6 | Diagnostic Products Corp. | 2000-02-28 |
| K993026 | ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALIBRATORS | Syva Co. | 2000-01-27 |
| K973414 | ACE PHENYTOIN REAGENT, AED CALIBRATORS | Schiapparelli Biosystems, Inc. | 1997-11-04 |
| K963840 | CEDIA PHENYTOIN II ASSAY | Boehringer Mannheim Corp. | 1996-11-20 |
| K943980 | IL TEST PHENYTION CALIBRATORS | Instrumentation Laboratory CO | 1995-05-01 |
| K945725 | PHENYTION EIA TEST | Diagnostic Reagents, Inc. | 1995-02-03 |
| K944085 | ACE(TM) CEDIA(R) PHENYTOIN ASSAY | Schiapparelli Biosystems, Inc. | 1994-12-28 |
| K941142 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE PHENYTOIN | Eastman Kodak Company | 1994-06-13 |
| K932686 | PARAMAX(R) PHENYTOIN REAGENT | Baxter Diagnostics, Inc. | 1993-11-26 |
| K915755 | BIOTRACK PHENYTOIN TEST CARTRIDGE | Biotrack, Inc. | 1992-07-23 |
| K913429 | EMIT(R) 2000 PHENYTOIN ASSAY/CALIBRATORS | Syva Co. | 1991-08-26 |
| K911056 | DU PONT DIMENSION(R) PHENYTOIN (PTN) METHOD | E.I. Dupont DE Nemours & Co., Inc. | 1991-04-03 |
| K905689 | CEDIA PHENYTOIN ASSAY | Microgenics Corp. | 1991-01-17 |
| K904815 | QMS TM- PHENYTOIN | Seradyn, Inc. | 1990-11-06 |
| K902952 | IL PHENYTOIN ASSAY SYSTEM | Instrumentation Laboratory CO | 1990-08-22 |
| K901080 | EZ-BEAD PHENYTOIN ENZYME IMMUNOASSAY KIT | Immunotech Corp. | 1990-05-17 |
| K896074 | VISION PHENYTOIN | Abbott Laboratories | 1989-11-17 |
| K874856 | EMIT CONVENIENCE PACK: PHENYTOIN ASSAY | Syva Co. | 1988-01-05 |
| K870953 | PHENYTOIN FPIA REAGENT SET | Sigma Diagnostics, Inc. | 1987-03-31 |
| K864925 | EMDS TM PHENYTOIN (PTN) TESTPACK, ITEM #67676/95 | Em Diagnostic Systems, Inc. | 1987-01-07 |
| K864554 | EASY-TEST PRIMIDONE ITEM NO. 67---/95 | Em Diagnostic Systems, Inc. | 1987-01-07 |
| K863403 | PHENYTOIN, AS PERFORMED ON TECHNICON RA SYSTEMS | Technicon Instruments Corp. | 1986-09-29 |
| K855026 | ACCULEVEL PHENYTOIN TEST | Syva / A Syntex Co. | 1986-08-25 |
| K862349 | EASY-TEST EMIT PHENYTOIN(PHTN) ITEM # 67535/93 | Em Diagnostic Systems, Inc. | 1986-07-07 |
| K860286 | IL TEST PHENYTOIN | Allied Instrumentation Laboratory | 1986-03-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613336121474 | ONLINE TDM Phenytoin | Roche Diagnostics GmbH | 2020-03-05 |
| 07613336157787 | ONLINE TDM Phenytoin | Roche Diagnostics GmbH | 2020-03-05 |
| 00380740135515 | Alinity | ABBOTT LABORATORIES | 2018-12-04 |
| 00630414596037 | Atellica CH Phny | Siemens Healthcare Diagnostics Inc. | 2017-12-19 |
| 00630414121758 | ADVIA Centaur® PHTN MCM | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414964492 | IMMULITE®/IMMULITE® 1000 Systems PHN Phenytoin | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2016-09-24 |
| 00630414961903 | IMMULITE® 2000 Systems PHN Phenytoin | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2016-09-24 |
| 00630414953410 | IMMULITE® Systems SDC CONTROL Serum Drug Control Module | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2016-09-24 |
| 00630414561936 | ADVIA® Chemistry PHNY_2 Phenytoin_2 Reagents | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414209135 | ADVIA Centaur® PHTN | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414209128 | ADVIA Centaur® PHTN | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414121772 | ADVIA Centaur® PHTN Calibrator | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414121765 | ADVIA Centaur® Systems, ACS:180® Systems PHTN Calibrator | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768023217 | Emit® 2000 Phenytoin Assay | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768017391 | Syva® Emit® 2000 Phenytoin Calibrators | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768017384 | Syva® Emit® 2000 Phenytoin Assay | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768015410 | Dimension Vista® Flex® reagent cartridge PTN | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768005619 | Dimension® Flex® reagent cartridge PTN | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 05055273206418 | PHT | RANDOX LABORATORIES LIMITED | 2016-09-24 |
| 04015630997138 | ONLINE TDM Phenytoin | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630999378 | Phenytoin | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630997763 | Phenytoin | Roche Diagnostics GmbH | 2016-09-20 |
| 00884883001220 | CEDIA Phenytoin II Assay | Microgenics Corporation | 2016-09-12 |
| 10758750004690 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2016-08-26 |
| 15099590232030 | Synchron | Beckman Coulter, Inc. | 2016-08-24 |
| 00380740001797 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |
| 00380740001803 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |
| 00380740102708 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |