FDA.reportPublic FDA data

510(k) K802037

Device
VITAMIN B12 FOLATE RADIOASSAY
Applicant
CORNING MEDICAL & SCIENTIFIC
510(k) number
K802037
Product code
CCN  
Decision
Substantially Equivalent (SESE)
Decision date
1980-11-21
Date received
1980-08-22
Regulation
868.2300
Classification name
Flowmeter, Nonback-pressure Compensated, Bourdon Gauge
Medical specialty
Anesthesiology
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CCN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K934945FLOWMETER NIPPLE ADAPTORCardio-Search , Ltd.1993-11-17
K920783OXYGEN FLOW CONTROLLERPuritan Bennett Corp.1992-09-18
K872038NEB-U-VENTDesign Technologies, Inc.1987-08-10
K871262MODIFIED NOFLO IDesign Technologies, Inc.1987-07-21
K863613NO-FLO IDesign Technologies, Inc.1986-12-15
K863657OXYGEN CONSERVATORSalter Labs1986-10-15
K863659FLOW INTERRUPTION INDICATORSalter Labs1986-10-15
K823775BORDON GAGE REGULATOR #BGTimeter Instrument Corp.1983-01-14

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases