Product code CDX— Clinical Chemistry
EMIT CENTRIFICHEM THYROXINE ASSAY
- Classification name
- Radioimmunoassay, Total Thyroxine
- Device class
- Class 2
- Regulation
- 21 CFR 862.1700
- Advisory panel
- Clinical Chemistry
- Total cleared
- 121
- First cleared
- Most recent
Market context for product code CDX
FDA has cleared devices under product code CDX between 1976 and 1996, filed by 75 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- 1996
- 1995
- 1994
- 1993
- 1992
- 1991
- 1990
- 1989
- 1988
- 1987
- 1986
- 1985
- 1984
- 1983
- 1982
Top applicants under product code CDX
Recent clearances under product code CDX
1–100 of 121- K961490 — ELECSYS T4 ASSAY
- K954312 — ACTIVE THYROXINE RIA
- K943416 — DELFIA NEONATAL THYROXINE KIT
- K934384 — AXSYM(TM) TOTAL T4
- K932980 — TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116
- K933426 — STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO
- K931295 — IQ TT4 ASSAY
- K926563 — AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KIT
- K925110 — ABBOTT IMX T4
- K925109 — ABBOTT TDX/TDXFLX TT4
- K922945 — TECHNICON DAX SYSTEM THYROXINE (T4) METHOD
- K921935 — THYROXINE (T4) COATED TUBE RIA
- K920766 — T4 EIA BEAD ASSAY
- K915235 — CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KIT
- K912541 — MILENIA TOTAL T4, CATALOG: MKT41,5
- K911985 — LUMATAG T4 CHEMILUMINESCENCE ASSAY
- K904816 — THYROXINE MONOCLONAL ANTIBODY SOLID PHASE RADIOIMM
- K905532 — CIBA CORNING ACS T4 IMMUNOASSAY
- K902922 — MICROZYME T4 ENZYME IMMUNOASSAY KIT
- K901475 — CLINICAL ASSAYS(TM) GAMMACOAT(TM) M [125I] T4
- K901939 — NEOCOAT T4
- K894575 — TECHNICON RA SYSTEM THYROXINE T4 METHOD
- K883559 — DELFIA THYROXINE (T4) KIT
- K874623 — FIAGEN(TM) THYROXINE (T4), CATALOGUE #101-101
- K875081 — IMMPULSE T4 ASSAY REAGENTS
- K872286 — CIBA CORNING MAGIC LITE FT4 IMMUNOASSAY
- K871303 — DELFIA(TM) THYROXINE (T4) KIT
- K871008 — MICROMEDIC NEONATAL T4 KIT
- K870965 — CIBA CORNING MAGIC(R) LITE T4 IMMUNOASSAY
- K870573 — T4 NO SPIN(TM) COATED TUBE RADIOIMMUNOASSAY KIT
- K864560 — IQ T4 IMMUNOASSAY
- K861320 — MMS T4 RIA KIT
- K860421 — STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY
- K854798 — T-4 RIASSAY
- K854324 — PANCOAT T4 COATED TUBE RADIOIMMUNOASSAY KIT
- K840852 — IMMPULSE T4 ASSAY REAGENTS
- K834023 — BIO-SCIENCE LABORATORIES T4 REAGENT
- K833850 — T4 RIA
- K833745 — RIACOAT T-4
- K832468 — T4-RIA SINGLE REAGENT
- K831533 — MAGIC T4 125I RADIOIMMUNOASSAY
- K831107 — COAT-A-COUNT NEONATAL T4 KIT RIA KIT
- K830642 — PHASE THYROXINE RADIOIMMUNOASSAY KIT
- K823265 — MONOCLONAL ANTIBODY T4 RADIO-KIT
- K823053 — NML-TETRA-TUBE RIA
- K823004 — BIO MAG TOTAL T4 RADIOIMMUNOASSAY KIT
- K822399 — LEECO T4 QUANT DIAGNOSTICS TEST KIT
- K821554 — ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KIT
- K820725 — SPAC T4 RIA TEST KIT
- K821141 — ENDAB T4 ENZYME IMMUNOASSAY KIT
- K821101 — TOTAL RADIOIMMUNOASSAY KIT
- K820886 — THYROXINE T4 KIT
- K811787 — QUANTAPHASE T-4 RIA
- K811315 — COAT-A-COUNT T4 RIA KIT
- K811070 — 125 I-T4 RIA TEST KIT
- K810811 — T4 RIA KIT
- K803046 — IMMU-TRACE T4 RIA PROCEDURE
- K802573 — SERUM T4 BY ENZYME IMMUNOASSAY
- K802469 — T4 RADIOIMMUNOASSAY KIT
- K802456 — T4-SQUIBB RIA KIT
- K801105 — THYROXINE RADIOIMMUNOASSAY KIT
- K800203 — RIA PHASE T4
- K800385 — ANALYTE T4-THYROXINE
- K800300 — AMERLEX T-4 RIA KIT
- K800169 — AMES RIALYZE - CHROMATOGRAPHY TUBES
- K800187 — EMC-M-175, THYROXINE - 100 TUBES
- K792599 — TIPSEP-T4(RIA) T4 RADIOIMMUNOASSAY
- K792188 — TETRABEAD - 125 T4 SOLID PHASE DIAG. KIT
- K791664 — IMMUCHEM COVALENT COAT SOLID PHASE ASSAY
- K791368 — VENTRE/SEP T4 TEST SET
- K791231 — DAC-CEL T4
- K790576 — QUANTIMUNE T-4 FIA
- K790907 — AUTOPAK TEST DELIVERY SYSTEM
- K790800 — CENTRIA T4 RIA TEST SET
- K790665 — NEONATAL TY AUTOPAK TEST DELIVERY SYSTEM
- K790495 — THYROXINE RIA KIT
- K790477 — TY RIA KIT, AUTOMATED ASSAY SYSTEM
- K782109 — RIA KIT, GAMMACOAT
- K782103 — RIA KIT, NEONATAL T4
- K781222 — ACCUSCREEN T4
- K781483 — ORTHO*T-4 RIA (PEG) KIT
- K781181 — CLINIRIA TOTAL T-4 (RIA) TEST
- K781182 — MICRO THYROXINE REAGENT SYSTEM
- K781235 — IV VITRO GAMMADAB T4 RIA KIT
- K780854 — IN VITRO NEONATAL T4
- K780707 — T4-RIA KIT
- K780672 — 125 I-T4 RIA REAGENT
- K780639 — EMIT CENTRIFICHEM THYROXINE ASSAY
- K780644 — RADIOASSAY FOR TOTAL SERUM THYROXINE
- K780401 — THYRO-ZYME-T4 ASSAY KIT
- K780308 — OREIA-T4
- K780423 — STIKSEP-T4 RIA KIT
- K780121 — REAGENTS, MANUEAL, ASSAY, THYROXINE
- K780219 — ANALYSIS SYS., EMIT MAN. THYROXINE ASSAY
- K780050 — THYROXINE STDS. IN HUMAN SERUM
- K772330 — T4 RIA KIT
- K771415 — RIA FOR SERUM THYROXINE
- K772170 — EMIT CENTRIFICHEM THYROXINE ASSAY
- K771609 — PEDIATRIC THYROXINE TEST SYS. T4
- K772096 — IN VITRO DIAGNOSTIC REAGENT
Data sourced from openFDA. This site is unofficial and independent of the FDA.