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510(k) K791143

Device
SICKLE-CELL F TEST
Applicant
ISOLAB, INC.
510(k) number
K791143
Product code
KQI  
Decision
Substantially Equivalent (SESE)
Decision date
1979-07-17
Date received
1979-06-18
Regulation
864.7455
Classification name
Assay, Fetal Hemoglobin
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KQI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K880653HBF DILUENTHelena Laboratories1988-04-21
K812226HELENA HBF QUIPLATE CONTROLHelena Laboratories1981-09-01
K810475HELENA HEMOGLOBIN F CONTROLSHelena Laboratories1981-03-26

Legacy Summary#

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FDA Review#

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