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510(k) K781895

Device
BLOOD GROUP SUBSTANCE B
Applicant
NORTH AMERICAN BIOLOGICALS, INC.
510(k) number
K781895
Product code
KSX  
Decision
Substantially Equivalent (SESE)
Decision date
1978-12-20
Date received
1978-11-06
Regulation
864.9160
Classification name
Substance, Blood Grouping Of Non-human Origin For In Vitro Diagnostic Use
Medical specialty
Hematology
Review panel
Hematology
Device class
2
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 KSX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K802533GAMMA LEWIS BLOOD GROUP SUBSTANCEGamma Biologicals, Inc.1980-11-12
K802534GAMMA PI BLOOD GROUP SUBSTANCEGamma Biologicals, Inc.1980-11-12
K800916P1 BLOOD GROUP SUBSTANCETravenol Laboratories, S.A.1980-05-08
K781862BLOOD GROUP SUBSTANCE ANorth American Biologicals, Inc.1978-12-20
K781896BLOOD GROUP SUBSTANCE A,BNorth American Biologicals, Inc.1978-12-20
K771487LEWIS BLOOD GROUP SUBSTANCEOrtho Diagnostics, Inc.1977-11-08
K771488P1 BLOOD GROUP SUBSTANCEOrtho Diagnostics, Inc.1977-11-08

Legacy Summary#

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FDA Review#

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