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510(k) K910827

Device
ABL520 BLOOD GAS SYSTEM
Applicant
RADIOMETER AMERICA, INC.
510(k) number
K910827
Product code
GHS  
Decision
Substantially Equivalent (SESE)
Decision date
1991-07-09
Date received
1991-02-27
Regulation
864.7425
Classification name
Assay, Carboxyhemoglobin
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DONALD L BAKER
Address
811 Sharon Dr. Westlake OH US 44145 44145

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GHS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K974805CO-STAT(TM) END TIDAL BREATH ANALYZERNatus Medical, Inc.1998-03-11
K790943TRISEDTA-BORATE ELECTROPHORESIS FILM AGACorning Medical & Scientific1979-06-22
K771263RADIOMHTER OSM-2 HEMOXIMETERThe London Co.1977-08-03
K770209ECOLYZER CARBOXIMETERIadec, Inc.1977-03-07

Legacy Summary#

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FDA Review#

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