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510(k) K830843

Device
BLOOD GAS SOLUTIONS & CO-OXIMETER SOLU-
Applicant
RNA MEDICAL CORP.
510(k) number
K830843
Product code
JKT  
Decision
Substantially Equivalent (SESE)
Decision date
1983-04-28
Date received
1983-03-17
Regulation
862.3220
Classification name
Gas Chromatograph, Carbon-monoxide
Medical specialty
Toxicology
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 JKT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K823535DILUENT, ZEROING SOLUTION & CO-OX/ISEShaban Mfg. Co.1983-01-28

Legacy Summary#

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FDA Review#

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