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510(k) K792546

Device
FETAL CHECK
Applicant
ALTA DIAGNOSTICS, INC.
510(k) number
K792546
Product code
KJR  
Decision
Substantially Equivalent (SESE)
Decision date
1979-12-18
Date received
1979-12-10
Regulation
864.1850
Classification name
Erythrosin B
Medical specialty
Hematology
Review panel
Pathology
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 KJR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K842833PMK PRIMARY MONKEY KIDNEY-CELLSBartels Immunodiagnostic Supplies, Inc.1984-08-28
K842834HEP-2 CELLSBartels Immunodiagnostic Supplies, Inc.1984-08-28

Legacy Summary#

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FDA Review#

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