Product code DIP— Clinical Toxicology

FDA has cleared 44 devices under product code DIP between 1977 and 2008, filed by 26 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20081 clearance
• 20071 clearance
• 20031 clearance
• 20012 clearances
• 20002 clearances
• 19971 clearance
• 19961 clearance
• 19952 clearances
• 19942 clearances
• 19931 clearance
• 19921 clearance
• 19913 clearances
• 19903 clearances
• 19891 clearance
• 19881 clearance

• Syva Co.10 clearances
• Abbott Laboratories4 clearances
• Em Diagnostic Systems, Inc.3 clearances
• E.I. Dupont DE Nemours & Co., Inc.3 clearances
• Schiapparelli Biosystems, Inc.2 clearances
• Instrumentation Laboratory CO2 clearances
• Ventrex Laboratories, Inc.1 clearance
• Thermo Electron OY1 clearance
• Technicon Instruments Corp.1 clearance
• Syva / A Syntex Co.1 clearance

• K080696 — ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01Abbott Laboratories·2008-09-11
• K063145 — PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLSThermo Electron OY·2007-10-17
• K030428 — ROCHE ONLINE TDM PHENYTOINRoche Diagnostics Corp.·2003-04-28
• K011393 — RANDOX PHENYTOINRandox Laboratories, Ltd.·2001-12-04
• K011347 — EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229Syva Co.·2001-05-17
• K000006 — IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2KPN6Diagnostic Products Corp.·2000-02-28
• K993026 — ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALIBRATORSSyva Co.·2000-01-27
• K973414 — ACE PHENYTOIN REAGENT, AED CALIBRATORSSchiapparelli Biosystems, Inc.·1997-11-04
• K963840 — CEDIA PHENYTOIN II ASSAYBoehringer Mannheim Corp.·1996-11-20
• K943980 — IL TEST PHENYTION CALIBRATORSInstrumentation Laboratory CO·1995-05-01
• K945725 — PHENYTION EIA TESTDiagnostic Reagents, Inc.·1995-02-03
• K944085 — ACE(TM) CEDIA(R) PHENYTOIN ASSAYSchiapparelli Biosystems, Inc.·1994-12-28
• K941142 — KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE PHENYTOINEastman Kodak Company·1994-06-13
• K932686 — PARAMAX(R) PHENYTOIN REAGENTBaxter Diagnostics, Inc.·1993-11-26
• K915755 — BIOTRACK PHENYTOIN TEST CARTRIDGEBiotrack, Inc.·1992-07-23
• K913429 — EMIT(R) 2000 PHENYTOIN ASSAY/CALIBRATORSSyva Co.·1991-08-26
• K911056 — DU PONT DIMENSION(R) PHENYTOIN (PTN) METHODE.I. Dupont DE Nemours & Co., Inc.·1991-04-03
• K905689 — CEDIA PHENYTOIN ASSAYMicrogenics Corp.·1991-01-17
• K904815 — QMS TM- PHENYTOINSeradyn, Inc.·1990-11-06
• K902952 — IL PHENYTOIN ASSAY SYSTEMInstrumentation Laboratory CO·1990-08-22
• K901080 — EZ-BEAD PHENYTOIN ENZYME IMMUNOASSAY KITImmunotech Corp.·1990-05-17
• K896074 — VISION PHENYTOINAbbott Laboratories·1989-11-17
• K874856 — EMIT CONVENIENCE PACK: PHENYTOIN ASSAYSyva Co.·1988-01-05
• K870953 — PHENYTOIN FPIA REAGENT SETSigma Diagnostics, Inc.·1987-03-31
• K864554 — EASY-TEST PRIMIDONE ITEM NO. 67---/95Em Diagnostic Systems, Inc.·1987-01-07
• K864925 — EMDS TM PHENYTOIN (PTN) TESTPACK, ITEM #67676/95Em Diagnostic Systems, Inc.·1987-01-07
• K863403 — PHENYTOIN, AS PERFORMED ON TECHNICON RA SYSTEMSTechnicon Instruments Corp.·1986-09-29
• K855026 — ACCULEVEL PHENYTOIN TESTSyva / A Syntex Co.·1986-08-25
• K862349 — EASY-TEST EMIT PHENYTOIN(PHTN) ITEM # 67535/93Em Diagnostic Systems, Inc.·1986-07-07
• K860286 — IL TEST PHENYTOINAllied Instrumentation Laboratory·1986-03-05
• K860048 — DETERMINATION OF PHENYTOIN (DIPHENYLHYDANTOIN)Clinical Data, Inc.·1986-01-22
• K850712 — EMIT QST PHENYTOIN ASSAY -MONOCLONAL ANTIBODYSyva Co.·1985-03-20
• K842092 — SERALYZER ARIS PHENYTOIN REAGENT STRIPSMiles Laboratories, Inc.·1985-03-19
• K844991 — EMIT PHENYTOIN ASSAYSyva Co.·1985-01-23
• K843209 — PHENYTOIN ACA ANALYTICAL TEST PACKE.I. Dupont DE Nemours & Co., Inc.·1984-10-11
• K842161 — VENTREZYME PHENYTOIN KIT IMMUNOASSAYVentrex Laboratories, Inc.·1984-07-09
• K834406 — EMIT QST PHENYTOIN ASSAYSyva Co.·1984-02-03
• K833806 — CHEMKIT PHENYTOIN DIAG. KITAbbott Laboratories·1984-01-30
• K832419 — A-GENT PHERYTOINAbbott Laboratories·1983-09-01
• K832033 — EMIT AED PHENYTOIN ASSAYSyva Co.·1983-08-01
• K811745 — VIRGO IPA FOR DETECTION OF PHENYTOINElectro-Nucleonics Laboratories, Inc.·1981-07-10
• K780218 — ANALYZER, EMIT AED ASSAYS TO CENTRIFICHESyva Co.·1978-03-03
• K772179 — EMIT ANTIEPILEPTIC DRUG ASSAYSSyva Co.·1977-12-20
• K771233 — PHENYTOIN ANALYTICAL TEST PACKSE.I. Dupont DE Nemours & Co., Inc.·1977-07-15