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Medical device manufacturer

Ciba Corning Diagnostics Corp.

Ciba Corning Diagnostics Corp. holds 125 FDA 510(k) clearances across 60 product codes. Median elapsed review time is 70 days. openFDA lists no recall records naming the company.

Updated · ingest status · JSON

510(k) clearances
125
Product codes
60
Median review
70 days
Recall records
0

How does FDA spell Ciba Corning Diagnostics Corp.?

FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.

Which product codes does Ciba Corning Diagnostics Corp. file in?

60 product codes, ranked by how much they file in each.

Product codes this company holds clearances in, with their median elapsed review time in each.
CodeDeviceClearancesMedian reviewLatest
JJYMulti-Analyte Controls, All Kinds (Assayed)1348 days
CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph756 days
DHBSystem, Test, Radioallergosorbent (Rast) Immunological7100 days
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use785 days
CDDRadioassay, Vitamin B12463 days
JGSElectrode, Ion Specific, Sodium438 days
JLWRadioimmunoassay, Thyroid-Stimulating Hormone455 days
CDXRadioimmunoassay, Total Thyroxine336 days
CEPRadioimmunoassay, Luteinizing Hormone324 days
JHIVisual, Pregnancy Hcg, Prescription Use328 days
KHQRadioassay, Triiodothyronine Uptake356 days
LJCEnzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)376 days
CDPRadioimmunoassay, Total Triiodothyronine256 days
CECRadioimmunoassay, Free Thyroxine271 days
CFTRadioimmunoassay, Prolactin (Lactogen)220 days
CGJRadioimmunoassay, Follicle-Stimulating Hormone228 days
CGNAcid, Folic, Radioimmunoassay272 days
CHPRadioimmunoassay, Estradiol262 days
DBFFerritin, Antigen, Antiserum, Control235 days
DGCIge, Antigen, Antiserum, Control271 days
DIFDrug Mixture Control Materials262 days
DONRadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.274 days
JFTFluorometric, Cortisol2127 days
JHXFluorometric Method, Cpk Or Isoenzymes222 days
JJSControls For Blood-Gases, (Assayed And Unassayed)29 days

Showing the 25 they file in most, of 60.

Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.

Source: openFDA device/510k · retrieved

Has Ciba Corning Diagnostics Corp. had a recall?

openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.

Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.

Source: openFDA device/recall · retrieved

What has Ciba Corning Diagnostics Corp. cleared recently?

Most recent 510(k) clearances for this company, newest first.
510(k)DeviceCodeDecisionElapsed days
K962559ACS CORTISOL IMMUNOASSAYJFT127
K963251CIBA CORNING ACS;180 DPD ASSAYJMM57
K961807CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4GLK77
K961657CIBA CORNING 400 SYSTEMCHL56
K962021CIBA CORNING 348 SYSTEMCHL32
K962126ACS CKMB II IMMUNOASSAYJHS18
K962041ACS LH2 IMMUNOASSAYCEP24
K961510ACS FRT4 IMMUNOASSAYJJX59
K960246LIQUID CARDIAC MARKER 1,2,3 ASSAYEDJJT98
K955873ACS PHENYTOIN ASSAYLGR76

Source: openFDA device/510k · retrieved

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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.