Product code KLI— Clinical Chemistry
CEDIA T4 MAB ASSAY
- Classification name
- Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- Device class
- Class 2
- Regulation
- 21 CFR 862.1700
- Advisory panel
- Clinical Chemistry
- Total cleared
- 86
- First cleared
- Most recent
Market context for product code KLI
FDA has cleared devices under product code KLI between 1977 and 2016, filed by 55 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- 2016
- 2013
- 2011
- 2009
- 2003
- 2002
- 2000
- 1999
- 1998
- 1997
- 1996
- 1995
- 1994
- 1993
- 1992
Top applicants under product code KLI
Recent clearances under product code KLI
- K160495 — VITROS® Automation Solutions
- K131515 — ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT
- K103484 — GSP NEONATAL THYROXINE (T4)
- K082638 — ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL
- K030860 — ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300
- K023369 — ACCESS TOTAL T4 ASSAY
- K001603 — REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105)
- K000600 — SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS
- K991432 — BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007
- K982298 — OPTICOAT T4 EIA KIT
- K983440 — ABBOTT ARCHITECT TOTAL T4
- K981377 — ACE T4 REAGENT T4 CALIBRATORS
- K972974 — ACCUWELL T4-EIA
- K971709 — TOTAL THROXINE MICROPLATE EIA(225-300)
- K971269 — DSL ACTIVE T4 EIA
- K971203 — SYNCHRON SYSTEMS THYROXINE REAGENT
- K964721 — VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005)
- K951014 — ISOLAB'S T4 TEST KIT
- K962211 — UBI MAGIWEL THYROXINE (T4) QUANTITATIVE
- K952751 — BIOCIRCUITS IOS T4/TU TEST CARTRIDGES
- K953837 — BIOCIRCUITS IOS T4 TEST CARTRIDGE
- K951321 — RADIAS NEONATAL T4 ENZYME IMMUNOASSAY
- K950588 — T4 MICROWELL EIA (ENZYME IMMUNOASSAY0
- K946163 — RADIAS TOTAL T4 ENZYME IMMUNOASSAY
- K944703 — THYROXINE ENZYME IMMUNOASSAY
- K943019 — CEDIA T4 MAB ASSAY
- K942575 — CEDIA T4 MAB ASSAY
- K941042 — CEDIA T4 MAB ASSAY
- K935880 — CEDIA T4 MAB ASSAY MODIFICATION
- K932605 — COBAS (R) CORE T4 EIA
- K926475 — ACCESS(R) THYROXINE ASSAY
- K926393 — VIDAS THYROXINE (T4) ASSAY (T4)
- K922433 — VISTA THYROXINE (T-4) ASSAY -- MODIFICATION
- K921904 — THYROXINE (FPIA) KIT
- K920712 — MEDIX BIOTECH THROXINE ENZYME IMMUNOASSAY TEST KIT
- K915194 — CEDIA T4
- K912616 — TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES
- K911217 — SR1 T4 ENZYME IMMUNOASSAY (MAGNETIC SOLID-PHASE)
- K910261 — IMMULITE(TM) TOTAL T4
- K903095 — IL THYROXINE (T4) ASSAY SYSTEM
- K897072 — NDS THYROXINE TEST KIT & NDS THYROXINE CALIBRATOR
- K897193 — OPUS T4 TEST SYSTEM
- K897144 — THYROXIN(T4) ENZYME IMMUNOASSAY TEST KIT
- K896982 — AIA-PACK T4
- K896865 — VITRO T4-EIA-XT
- K896329 — D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA.
- K892853 — T4 CLASP-BEAD EIA KIT
- K890831 — EMIT CONVENIENCE PACK: THYROXINE ASSAY
- K884260 — THYROXINE MICROASSAY
- K885141 — EMIT THYROXINE ASSAY
- K885258 — ACA THYROXINE (T4 E) METHOD
- K884700 — ANALYST THYROXINE (T4) ROTOR
- K884634 — MODIFIED CEDIA TOTAL T4 ASSAY
- K881357 — EMIT CONVENIENCE PACK: THYROXINE ASSAY
- K880620 — EMIT THYROXINE ASSAY
- K880662 — VISION(R) THYROXINE (T4)
- K874866 — T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE
- K874603 — CIBA CORNING T4 LIPIA (LIPOSOME IMMUNOASSAY)
- K873976 — AMERLITE TT4 ASSAY (240/480/144 TEST KITS)
- K873518 — AFFINITY TOTAL THYROXINE IMMUNIT
- K872192 — IMMUBEAD T4 ENZYME IMMUNOASSAY KIT
- K862233 — CIBA CORNING PRISMA T4 LIPIA (LIPOSOME)
- K854971 — V-TREND EIA T4 ENZYME IMMUNOASSAY TEST KIT
- K852164 — CEDIA TOTAL T4 ASSAY
- K841576 — TECHNICON RA-1000 SYS T4-THYROXINE
- K841601 — TERUMO SENSIBEAD THYROXINE EIA KIT
- K840473 — VENTREZYME T4 IMMUNOASSAY T4
- K840241 — THYROXINE EMIA
- K834102 — RA-1000 SYS-T4(THYROXINE)SERUM ANAL
- K834210 — STRATUS TOTAL THYROXINE FLUOROMETRIC
- K830683 — TDX THYROXINE
- K830769 — FEKAL CON-TRATE SYSTEM
- K830136 — PARAMOUNT THYROXINE ASSAY
- K823751 — SOPHEIA THYROXINE EIA KIT
- K823034 — SYVA ADVANCE THYROXINE ASSAY
- K820750 — ENZYMUNE-TEST T4
- K810586 — EMIT-TFG PRISMA THYROXINE ASSAY
- K802693 — OREIA-Q-TY, ENZYME IMMUNOASSAY
- K801475 — APPLICATION OF EMIT AED ASSAYS
- K801288 — EMIT AAII THYROXINE ASSAY
- K800384 — SMAC SYSTEM, T4 METHOD
- K790848 — A-GENT QUANTICHROM T4 11A
- K790686 — EMIT CFA THYROXINE ASSAY
- K782085 — EMIT THYROXINE ASSAY
- K781828 — COMPUTER, 3500, GILFORD SYSTEM
- K770070 — ENIT ABA THYROXINE ASSAY
Data sourced from openFDA. This site is unofficial and independent of the FDA.