Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KLT — Predicate Candidate Screening
56 FDA 510(k) clearances under this product code; the 50 most recent screened below.
56 daysmedian FDA review time
213 days90th percentile
56clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K151578 | Carbamazepine Gen 4 | Roche Diagnostics Operations (Rdo) | 2015-10-22 | 133 | 0 |
| K123518 | ABBOTT CARBAMAZEPINE ASSAY | Microgenics Corporation | 2013-06-05 | 203 | 0 |
| K103627 | ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT | Abbott Laboratories | 2011-10-14 | 305 | 0 |
| K063131 | CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTR | Thermo Electron OY | 2007-10-05 | 357 | 0 |
| K042808 | ADVIA IMS CARBAMAZEPINE METHOD | Bayer Healthcare, LLC | 2005-02-08 | 119 | 0 |
| K031902 | ONLINE TDM CARBAMAZEPINE | Roche Diagnostics Corp. | 2003-09-17 | 89 | 0 |
| K011648 | RANDOX CARBAMAZEPINE | Randox Laboratories, Ltd. | 2002-01-15 | 231 | 0 |
| K010814 | EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229 | Syva Co., Dade Behring, Inc. | 2001-04-13 | 25 | 0 |
| K000903 | ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM | Bayer Corp. | 2000-05-18 | 58 | 0 |
| K000007 | IMMULITE CARBAMAZEPINE, IMMULITE 2000 CARBAMAZEPINE, CATALOG | Diagnostic Products Corp. | 2000-02-28 | 56 | 0 |
| K993987 | SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL | Syva Co. | 2000-01-27 | 64 | 0 |
| K993028 | ABBOTT AEROSET CARBAMAZEPINE ASSAY AND CALIBRATORS; MODELS 1 | Syva Co. | 2000-01-27 | 140 | 0 |
| K980283 | VITROS CHEMISTRY PRODUCTS CRBM SLIDES | Johnson & Johnson Clinical Diagnostics, Inc. | 1998-02-25 | 30 | 3 |
| K973535 | ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS | Schiapparelli Biosystems, Inc. | 1997-10-20 | 32 | 0 |
| K964765 | CHIRON DIAGNOSTICS ACS: 180 CARBAMAZEPINE ASSAY | Chiron Diagnostics Corp. | 1997-02-14 | 79 | 0 |
| K963673 | IMMAGE IMMUNOCHEMISTRY SYSTEM TDM (CAR,PHE,PHY, & THE) REAGE | Beckman Instruments, Inc. | 1997-02-04 | 144 | 0 |
| K964068 | CARBAMAZEPINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM | Bayer Corp. | 1996-12-13 | 64 | 0 |
| K962820 | CARBAMAZEPINE FLEX REAGENT CARTRIDGE | Dade Intl., Inc. | 1996-09-13 | 56 | 0 |
| K955644 | SYNCHRON SYSTEMS CARBAMAZEPINE TEST SYSTEM | Beckman Instruments, Inc. | 1996-02-16 | 66 | 4 |
| K955100 | CARBAMAZEPINE EIA TEST | Diagnostic Reagents, Inc. | 1995-12-13 | 35 | 0 |
| K942687 | IL TEST CARBAMAZEPINE, PN 181754-00; IL TEST CARBAMAZEPINE C | Instrumentation Laboratory CO | 1995-01-25 | 232 | 0 |
| K935374 | AXSYM CARBAMAZEPHINE | Abbott Laboratories | 1994-06-21 | 225 | 0 |
| K940374 | QMS CARBAMAZEPINE ASSAY | Seradyn, Inc. | 1994-06-02 | 127 | 0 |
| K933684 | IL TEST CARBAMAZEPHINE | Instrumentation Laboratory CO | 1993-10-01 | 64 | 0 |
| K926441 | ROCHE COBAS(R)-FP REAGENT FOR TOTAL T4 THYROX/CALI | Roche Diagnostic Systems, Inc. | 1993-05-26 | 154 | 0 |
| K915756 | BIOTRACK CARBAMAZEPINE TEST CARTRIDGE | Biotrack, Inc. | 1992-07-23 | 213 | 0 |
| K914857 | CEDIA(R) CARBAMAZEPINE ASSAY | Microgenics Corp. | 1992-01-15 | 78 | 0 |
| K913066 | EMIT(R) 2000 CARBAMAZEPINE ASSAY/CALIBRATORS | Syva Co. | 1991-07-30 | 20 | 0 |
| K901086 | ENZYMUN TEST(R) T4 (TOTAL THYROXINE) | Boehringer Mannheim Corp. | 1990-03-30 | 21 | 0 |
| K897114 | EMIT CONVENIENCE PACK: CARBAMAZEPINE ASSAY | Syva Co. | 1990-01-18 | 23 | 0 |
| K896860 | OPUS CARBAMAZEPINE TEST SYSTEM | Pb Diagnostic Systems, Inc. | 1990-01-02 | 28 | 0 |
| K894519 | FPR CARBAMAZEPINE KIT | Colony Laboratories, Inc. | 1989-08-28 | 39 | 0 |
| K893507 | INNOFLUOR CARBAMAZEPINE REAGENT SET | Innotron of Oregon, Inc. | 1989-08-11 | 98 | 0 |
| K882961 | EMIT QST CARBAMAZEPINE ASSAY | Syva Co. | 1988-08-29 | 46 | 0 |
| K873282 | CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAY | Windsor Laboratories, Inc. | 1987-09-22 | 36 | 0 |
| K871254 | ACCULEVEL CARBAMAZEPINE TEST | Syva Co. | 1987-06-17 | 79 | 1 |
| K871306 | EMIT CARBAMAZEPINE ASSAY | Syva Co. | 1987-04-14 | 13 | 0 |
| K863842 | SERALYZER ARIS CARBAMAZEPINE STRIPS/MODU/CALI/CONT | Miles Laboratories, Inc. | 1987-01-14 | 105 | 0 |
| K864553 | EASY-TEST CARBAMAZEPINE ITEM NO. 67---/95 | Em Diagnostic Systems, Inc. | 1987-01-08 | 50 | 0 |
| K862916 | EZ-SCREEN: CANNABINOID | Environmental Diagnostics, Inc. | 1987-01-07 | 159 | 0 |
| K860047 | DETERMINATION OF CARBAMAZEPINE | Clinical Data, Inc. | 1986-01-22 | 16 | 0 |
| K853835 | EMIT QST CARBAMAZEPINE ASSAY | Syva Co. | 1985-10-01 | 15 | 0 |
| K850807 | COBAS FP REAGENTS FOR CARBAMAZEPINE | Roche Diagnostic Systems, Inc. | 1985-03-22 | 23 | 0 |
| K834052 | CHEMKIT CARBAMAZEPINE DIAGNOSTIC KIT | Abbott Laboratories | 1984-01-24 | 62 | 0 |
| K832720 | EMIT AED CARBAMAZEPINE ASSAY | Syva Co. | 1983-10-04 | 53 | 0 |
| K832766 | AMES TDA DISOPYRAMIDE TEST | Miles Laboratories, Inc. | 1983-09-29 | 44 | 0 |
| K832631 | A-GENT CARBAMAZEPINE | Abbott Laboratories | 1983-09-12 | 39 | 0 |
| K832447 | STRATUS CARBAMAZEPINE FLUROMETRIC | American Dade | 1983-09-12 | 49 | 0 |
| K831222 | CARBAMEZEPINE REAGENT TEST KIT | Beckman Instruments, Inc. | 1983-05-09 | 24 | 0 |
| K821945 | CARBAMAZEPINE FLOURESCENT IMMUNOASSAY | American Diagnostic Corp. | 1982-07-16 | 17 | 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