Product code KLT— Clinical Toxicology
EMIT CARBAMAZEPINE ASSAY
- Classification name
- Enzyme Immunoassay, Carbamazepine
- Device class
- Class 2
- Regulation
- 21 CFR 862.3645
- Advisory panel
- Clinical Toxicology
- Total cleared
- 56
- First cleared
- Most recent
Market context for product code KLT
FDA has cleared devices under product code KLT between 1978 and 2015, filed by 34 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.
Clearances per year
last 15 years- 2015
- 2013
- 2011
- 2007
- 2005
- 2003
- 2002
- 2001
- 2000
- 1998
- 1997
- 1996
- 1995
- 1994
- 1993
Top applicants under product code KLT
Recent clearances under product code KLT
- K151578 — Carbamazepine Gen 4
- K123518 — ABBOTT CARBAMAZEPINE ASSAY
- K103627 — ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORS
- K063131 — CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS
- K042808 — ADVIA IMS CARBAMAZEPINE METHOD
- K031902 — ONLINE TDM CARBAMAZEPINE
- K011648 — RANDOX CARBAMAZEPINE
- K010814 — EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229
- K000903 — ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM
- K000007 — IMMULITE CARBAMAZEPINE, IMMULITE 2000 CARBAMAZEPINE, CATALOG # LKCB1, LKCB5 & L2KCB2, L2KCB6
- K993028 — ABBOTT AEROSET CARBAMAZEPINE ASSAY AND CALIBRATORS; MODELS 1E12 AND 6E90
- K993987 — SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL
- K980283 — VITROS CHEMISTRY PRODUCTS CRBM SLIDES
- K973535 — ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS
- K964765 — CHIRON DIAGNOSTICS ACS: 180 CARBAMAZEPINE ASSAY
- K963673 — IMMAGE IMMUNOCHEMISTRY SYSTEM TDM (CAR,PHE,PHY, & THE) REAGENTS
- K964068 — CARBAMAZEPINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
- K962820 — CARBAMAZEPINE FLEX REAGENT CARTRIDGE
- K955644 — SYNCHRON SYSTEMS CARBAMAZEPINE TEST SYSTEM
- K955100 — CARBAMAZEPINE EIA TEST
- K942687 — IL TEST CARBAMAZEPINE, PN 181754-00; IL TEST CARBAMAZEPINE CALIBRATORS, PN 181762-00
- K935374 — AXSYM CARBAMAZEPHINE
- K940374 — QMS CARBAMAZEPINE ASSAY
- K933684 — IL TEST CARBAMAZEPHINE
- K926441 — ROCHE COBAS(R)-FP REAGENT FOR TOTAL T4 THYROX/CALI
- K915756 — BIOTRACK CARBAMAZEPINE TEST CARTRIDGE
- K914857 — CEDIA(R) CARBAMAZEPINE ASSAY
- K913066 — EMIT(R) 2000 CARBAMAZEPINE ASSAY/CALIBRATORS
- K901086 — ENZYMUN TEST(R) T4 (TOTAL THYROXINE)
- K897114 — EMIT CONVENIENCE PACK: CARBAMAZEPINE ASSAY
- K896860 — OPUS CARBAMAZEPINE TEST SYSTEM
- K894519 — FPR CARBAMAZEPINE KIT
- K893507 — INNOFLUOR CARBAMAZEPINE REAGENT SET
- K882961 — EMIT QST CARBAMAZEPINE ASSAY
- K873282 — CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAY
- K871254 — ACCULEVEL CARBAMAZEPINE TEST
- K871306 — EMIT CARBAMAZEPINE ASSAY
- K863842 — SERALYZER ARIS CARBAMAZEPINE STRIPS/MODU/CALI/CONT
- K864553 — EASY-TEST CARBAMAZEPINE ITEM NO. 67---/95
- K862916 — EZ-SCREEN: CANNABINOID
- K860047 — DETERMINATION OF CARBAMAZEPINE
- K853835 — EMIT QST CARBAMAZEPINE ASSAY
- K850807 — COBAS FP REAGENTS FOR CARBAMAZEPINE
- K834052 — CHEMKIT CARBAMAZEPINE DIAGNOSTIC KIT
- K832720 — EMIT AED CARBAMAZEPINE ASSAY
- K832766 — AMES TDA DISOPYRAMIDE TEST
- K832447 — STRATUS CARBAMAZEPINE FLUROMETRIC
- K832631 — A-GENT CARBAMAZEPINE
- K831222 — CARBAMEZEPINE REAGENT TEST KIT
- K821945 — CARBAMAZEPINE FLOURESCENT IMMUNOASSAY
- K820189 — CARBAMAZEPINE ASSAY
- K811952 — AMES TDA CARBAMAZEPINE TEST
- K802902 — CYBREX CARBAMAZEPINE
- K790255 — EMIT AED ASSAYS 3500 COMPUTER DIRECTED
- K781958 — ANALYTICAL TEST PACK, CARBAMAZEPINE
- K780466 — EMIT CARBAMAZEPINE ASSAY
Data sourced from openFDA. This site is unofficial and independent of the FDA.