DIP — Enzyme Immunoassay, Diphenylhydantoin Class II
FDA product code DIP covers "Enzyme Immunoassay, Diphenylhydantoin", a Class II medical device regulated under 21 CFR 862.3350. Submissions are reviewed by the Clinical Toxicology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |