Medical Device Manufacturer · US , East Walpole , MA

Ciba Corning Diagnostics Corp.

125 submissions · 125 cleared · Since 1986
125
Total
125
Cleared
0
Denied

Ciba Corning Diagnostics Corp. — FDA 510(k) Submissions

Ciba Corning Diagnostics Corp. has submitted 125 FDA 510(k) premarket notifications since 1986, of which 125 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Multi-analyte Controls, All Kinds (assayed), System, Test, Radioallergosorbent (rast) Immunological, Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph, Analyzer, Chemistry (photometric, Discrete), For Clinical Use, Radioimmunoassay, Thyroid-stimulating Hormone . Use the specialty filter in the sidebar to narrow results.

125 devices
1–25 of 125
ACS CORTISOL IMMUNOASSAY
K962559 · JFT Fluorometric, Cortisol · Chemistry
Nov 1996 127d
CIBA CORNING ACS;180 DPD ASSAY
K963251 · JMM Column Chromatography &... · Chemistry
Oct 1996 57d
CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4
K961807 · GLK Control, Hematocrit · Chemistry
Jul 1996 77d
CIBA CORNING 400 SYSTEM
K961657 · CHL Electrode Measurement,... · Chemistry
Jun 1996 56d
CIBA CORNING 348 SYSTEM
K962021 · CHL Electrode Measurement,... · Chemistry
Jun 1996 32d
ACS LH2 IMMUNOASSAY
K962041 · CEP Radioimmunoassay,... · Chemistry
Jun 1996 24d
ACS CKMB II IMMUNOASSAY
K962126 · JHS Differential Rate Kinetic... · Chemistry
Jun 1996 18d
ACS FRT4 IMMUNOASSAY
K961510 · JJX Single (specified)... · Chemistry
Jun 1996 59d
LIQUID CARDIAC MARKER 1,2,3 ASSAYED
K960246 · JJT Enzyme Controls (assayed... · Chemistry
Apr 1996 98d
ACS PHENYTOIN ASSAY
K955873 · LGR Fluorescence Polarization... · Toxicology
Mar 1996 76d
CIBA CORNING ACS ESTRADIOL-6 ASSAY
K954697 · CHP Radioimmunoassay, Estradiol · Chemistry
Dec 1995 62d
ACS PHENOBARBITAL
K953021 · DIS Enzyme Immunoassay,... · Toxicology
Dec 1995 165d
ACS GENTAMICIN
K953020 · LCD Enzyme Immunoassay,... · Toxicology
Aug 1995 34d
CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAY
K951169 · LGS Fluorescence Polarization... · Chemistry
Jun 1995 97d
CIBA CORNING ACS VANCOMYCIN IMMUNOASSAY
K951059 · LEH Radioimmunoassay, Vancomycin · Toxicology
Jun 1995 104d
CIBA CORNING ACS THYROID STIMULATING HORMONE (TSH-3) IMMUNOASSAY
K951796 · JLW Radioimmunoassay,... · Chemistry
Jun 1995 55d
CIBA CORNING ACS CORTISOL IMMUNOASSAY
K945367 · CGR Radioimmunoassay, Cortisol · Chemistry
May 1995 221d
CIBA CORNING 8-- SERIES CO-OXIMETER
K946206 · CHL Electrode Measurement,... · Chemistry
Jan 1995 40d
CERTAIN(R) ELITE LEVEL 1, 2 AND 3
K946224 · JJS Controls For Blood-gases,... · Chemistry
Jan 1995 77d
CIBA CORNING ACS FOLATE ASSAY
K943297 · CGN Acid, Folic,... · Chemistry
Dec 1994 157d
MODEL 644 SWEAT DILUENT
K935228 · CGZ Electrode, Ion-specific,... · Chemistry
Aug 1994 273d
CIBA CORNING ACS:180 AUTO CHEMILUMIN SYST, MODIF
K940810 · JJE Analyzer, Chemistry... · Chemistry
May 1994 90d
CIDBA CORNING ACS CORTISOL IMMUNOASSAY
K934317 · JFT Fluorometric, Cortisol · Chemistry
May 1994 254d
CIBA CORNING ACS FT3 IMMUNOASSAY
K940482 · CEC Radioimmunoassay, Free... · Chemistry
Apr 1994 83d
MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM
K934594 · DGC Ige, Antigen, Antiserum,... · Immunology
Apr 1994 209d

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