Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
DIP — Predicate Candidate Screening
44 FDA 510(k) clearances under this product code; the 50 most recent screened below.
48 daysmedian FDA review time
213 days90th percentile
44clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K080696 | ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIB | Abbott Laboratories | 2008-09-11 | 183 | 0 |
| K063145 | PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/N | Thermo Electron OY | 2007-10-17 | 366 | 0 |
| K030428 | ROCHE ONLINE TDM PHENYTOIN | Roche Diagnostics Corp. | 2003-04-28 | 77 | 2 |
| K011393 | RANDOX PHENYTOIN | Randox Laboratories, Ltd. | 2001-12-04 | 211 | 2 |
| K011347 | EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229 | Syva Co. | 2001-05-17 | 15 | 0 |
| K000006 | IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1 | Diagnostic Products Corp. | 2000-02-28 | 56 | 0 |
| K993026 | ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALI | Syva Co. | 2000-01-27 | 140 | 1 |
| K973414 | ACE PHENYTOIN REAGENT, AED CALIBRATORS | Schiapparelli Biosystems, Inc. | 1997-11-04 | 56 | 0 |
| K963840 | CEDIA PHENYTOIN II ASSAY | Boehringer Mannheim Corp. | 1996-11-20 | 57 | 0 |
| K943980 | IL TEST PHENYTION CALIBRATORS | Instrumentation Laboratory CO | 1995-05-01 | 328 | 0 |
| K945725 | PHENYTION EIA TEST | Diagnostic Reagents, Inc. | 1995-02-03 | 73 | 0 |
| K944085 | ACE(TM) CEDIA(R) PHENYTOIN ASSAY | Schiapparelli Biosystems, Inc. | 1994-12-28 | 128 | 0 |
| K941142 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE PHENYTOIN | Eastman Kodak Company | 1994-06-13 | 95 | 3 |
| K932686 | PARAMAX(R) PHENYTOIN REAGENT | Baxter Diagnostics, Inc. | 1993-11-26 | 176 | 0 |
| K915755 | BIOTRACK PHENYTOIN TEST CARTRIDGE | Biotrack, Inc. | 1992-07-23 | 213 | 0 |
| K913429 | EMIT(R) 2000 PHENYTOIN ASSAY/CALIBRATORS | Syva Co. | 1991-08-26 | 25 | 0 |
| K911056 | DU PONT DIMENSION(R) PHENYTOIN (PTN) METHOD | E.I. Dupont DE Nemours & Co., Inc. | 1991-04-03 | 26 | 1 |
| K905689 | CEDIA PHENYTOIN ASSAY | Microgenics Corp. | 1991-01-17 | 29 | 0 |
| K904815 | QMS TM- PHENYTOIN | Seradyn, Inc. | 1990-11-06 | 13 | 0 |
| K902952 | IL PHENYTOIN ASSAY SYSTEM | Instrumentation Laboratory CO | 1990-08-22 | 48 | 0 |
| K901080 | EZ-BEAD PHENYTOIN ENZYME IMMUNOASSAY KIT | Immunotech Corp. | 1990-05-17 | 71 | 0 |
| K896074 | VISION PHENYTOIN | Abbott Laboratories | 1989-11-17 | 29 | 0 |
| K874856 | EMIT CONVENIENCE PACK: PHENYTOIN ASSAY | Syva Co. | 1988-01-05 | 41 | 0 |
| K870953 | PHENYTOIN FPIA REAGENT SET | Sigma Diagnostics, Inc. | 1987-03-31 | 21 | 0 |
| K864554 | EASY-TEST PRIMIDONE ITEM NO. 67---/95 | Em Diagnostic Systems, Inc. | 1987-01-07 | 49 | 0 |
| K864925 | EMDS TM PHENYTOIN (PTN) TESTPACK, ITEM #67676/95 | Em Diagnostic Systems, Inc. | 1987-01-07 | 22 | 0 |
| K863403 | PHENYTOIN, AS PERFORMED ON TECHNICON RA SYSTEMS | Technicon Instruments Corp. | 1986-09-29 | 26 | 0 |
| K855026 | ACCULEVEL PHENYTOIN TEST | Syva / A Syntex Co. | 1986-08-25 | 252 | 0 |
| K862349 | EASY-TEST EMIT PHENYTOIN(PHTN) ITEM # 67535/93 | Em Diagnostic Systems, Inc. | 1986-07-07 | 17 | 0 |
| K860286 | IL TEST PHENYTOIN | Allied Instrumentation Laboratory | 1986-03-05 | 36 | 0 |
| K860048 | DETERMINATION OF PHENYTOIN (DIPHENYLHYDANTOIN) | Clinical Data, Inc. | 1986-01-22 | 16 | 0 |
| K850712 | EMIT QST PHENYTOIN ASSAY -MONOCLONAL ANTIBODY | Syva Co. | 1985-03-20 | 26 | 0 |
| K842092 | SERALYZER ARIS PHENYTOIN REAGENT STRIPS | Miles Laboratories, Inc. | 1985-03-19 | 299 | 0 |
| K844991 | EMIT PHENYTOIN ASSAY | Syva Co. | 1985-01-23 | 28 | 0 |
| K843209 | PHENYTOIN ACA ANALYTICAL TEST PACK | E.I. Dupont DE Nemours & Co., Inc. | 1984-10-11 | 57 | 0 |
| K842161 | VENTREZYME PHENYTOIN KIT IMMUNOASSAY | Ventrex Laboratories, Inc. | 1984-07-09 | 40 | 0 |
| K834406 | EMIT QST PHENYTOIN ASSAY | Syva Co. | 1984-02-03 | 51 | 0 |
| K833806 | CHEMKIT PHENYTOIN DIAG. KIT | Abbott Laboratories | 1984-01-30 | 90 | 0 |
| K832419 | A-GENT PHERYTOIN | Abbott Laboratories | 1983-09-01 | 41 | 0 |
| K832033 | EMIT AED PHENYTOIN ASSAY | Syva Co. | 1983-08-01 | 39 | 0 |
| K811745 | VIRGO IPA FOR DETECTION OF PHENYTOIN | Electro-Nucleonics Laboratories, Inc. | 1981-07-10 | 21 | 0 |
| K780218 | ANALYZER, EMIT AED ASSAYS TO CENTRIFICHE | Syva Co. | 1978-03-03 | 21 | 0 |
| K772179 | EMIT ANTIEPILEPTIC DRUG ASSAYS | Syva Co. | 1977-12-20 | 27 | 0 |
| K771233 | PHENYTOIN ANALYTICAL TEST PACKS | E.I. Dupont DE Nemours & Co., Inc. | 1977-07-15 | 8 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda