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Medical device manufacturer

Corning Medical & Scientific

Corning Medical & Scientific holds 111 FDA 510(k) clearances across 64 product codes. Median elapsed review time is 37 days. openFDA lists no recall records naming the company.

Updated · ingest status · JSON

510(k) clearances
111
Product codes
64
Median review
37 days
Recall records
0

How does FDA spell Corning Medical & Scientific?

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

Which product codes does Corning Medical & Scientific file in?

64 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
JLWRadioimmunoassay, Thyroid-Stimulating Hormone744 days
CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph422 days
JHXFluorometric Method, Cpk Or Isoenzymes427 days
JQPCalculator/Data Processing Module, For Clinical Use418 days
CDDRadioassay, Vitamin B123119 days
CECRadioimmunoassay, Free Thyroxine339 days
CFEElectrophoretic, Lactate Dehydrogenase Isoenzymes322 days
CGRRadioimmunoassay, Cortisol362 days
JBDSystem, Analysis, Electrophoretic Hemoglobin341 days
JJNApparatus, Electrophoresis, For Clinical Use339 days
JJOFlame Emission Photometer For Clinical Use337 days
JJSControls For Blood-Gases, (Assayed And Unassayed)318 days
JQTDensitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica320 days
KETFilters, Cell Collection, Tissue Processing328 days
LIBDevice, General Purpose, Microbiology, Diagnostic322 days
CDPRadioimmunoassay, Total Triiodothyronine244 days
CDXRadioimmunoassay, Total Thyroxine248 days
DBFFerritin, Antigen, Antiserum, Control218 days
JGSElectrode, Ion Specific, Sodium222 days
JHIVisual, Pregnancy Hcg, Prescription Use234 days
JJYMulti-Analyte Controls, All Kinds (Assayed)210 days
JMGRadioimmunoassay (Two-Site Solid Phase), Ferritin252 days
JQYPh Meter267 days
LCPAssay, Glycosylated Hemoglobin225 days
CCNFlowmeter, Nonback-Pressure Compensated, Bourdon Gauge191 days

Showing the 25 they file in most, of 64.

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 Corning Medical & Scientific 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 Corning Medical & Scientific cleared recently?

Most recent 510(k) clearances for this company, newest first.
510(k)DeviceCodeDecisionElapsed days
K875122DISPOSABLE STERILE SYRINGE FILTERSKET28
K872273CORNING EASY WASH ELISA PLATESLIB22
K872076CORNING DISPOSABLE ROLLER BOTTLESKJB17
K863789CORNING ELISA PLATESLIB7
K854024CORNING MAGIC MAB HCG RADIOIMMUNOASSAYJHI57
K853634CORNING CELL WELLS-MULTIPLE WELL PLATESKIZ17
K851939CORNING CERTAIN -ISEJIX42
K851329MAGIC MONOCLONAL ANTIBODY TSH(MAB TSH)RADIOIMMUNOAJLW70
K850806CORNING BLOOD COLLECTION CAPILLARY TUBESGIO26
K850617CORNING 780 FLUOROMETER/DENSITOMETERJQT25

Source: openFDA device/510k · retrieved

Watch what Corning Medical & Scientific files next

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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.