DIP — Enzyme Immunoassay, Diphenylhydantoin Class II
FDA Device Classification
Classification Details
- Product Code
- DIP
- Device Class
- Class II
- Regulation Number
- 862.3350
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K080696 | abbott laboratories | ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1 | September 11, 2008 |
| K063145 | thermo electron | PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS | October 17, 2007 |
| K030428 | roche diagnostics | ROCHE ONLINE TDM PHENYTOIN | April 28, 2003 |
| K011393 | randox laboratories | RANDOX PHENYTOIN | December 4, 2001 |
| K011347 | syva | EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229 | May 17, 2001 |
| K000006 | diagnostic products | IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2 | February 28, 2000 |
| K993026 | syva | ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALIBRATORS | January 27, 2000 |
| K973414 | schiapparelli biosystems | ACE PHENYTOIN REAGENT, AED CALIBRATORS | November 4, 1997 |
| K963840 | boehringer mannheim | CEDIA PHENYTOIN II ASSAY | November 20, 1996 |
| K943980 | instrumentation laboratory | IL TEST PHENYTION CALIBRATORS | May 1, 1995 |
| K945725 | diagnostic reagents | PHENYTION EIA TEST | February 3, 1995 |
| K944085 | schiapparelli biosystems | ACE(TM) CEDIA(R) PHENYTOIN ASSAY | December 28, 1994 |
| K941142 | eastman kodak | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE PHENYTOIN | June 13, 1994 |
| K932686 | baxter diagnostics | PARAMAX(R) PHENYTOIN REAGENT | November 26, 1993 |
| K915755 | biotrack | BIOTRACK PHENYTOIN TEST CARTRIDGE | July 23, 1992 |
| K913429 | syva | EMIT(R) 2000 PHENYTOIN ASSAY/CALIBRATORS | August 26, 1991 |
| K911056 | e.i. dupont de nemours and co | DU PONT DIMENSION(R) PHENYTOIN (PTN) METHOD | April 3, 1991 |
| K905689 | microgenics | CEDIA PHENYTOIN ASSAY | January 17, 1991 |
| K904815 | seradyn | QMS TM- PHENYTOIN | November 6, 1990 |
| K902952 | instrumentation laboratory | IL PHENYTOIN ASSAY SYSTEM | August 22, 1990 |