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510(k) K792582

Device
POLY-LEC SYSTEM
Applicant
GAMMA BIOLOGICALS, INC.
510(k) number
K792582
Product code
KSI  
Decision
Substantially Equivalent (SESE)
Decision date
1980-01-16
Date received
1979-12-14
Regulation
864.9550
Classification name
Lectins And Protectins
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 KSI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K820368LECTIN-AAmerican Dade1982-04-14
K813413LECTIN HAmerican Dade1982-03-04
K792583GAMMA ARACHIS HYPOGEA LECTINGamma Biologicals, Inc.1980-01-16

Legacy Summary#

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FDA Review#

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