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510(k) K842526

Device
AMIZYME-LEISHMANIA SPP. TEST KIT
Applicant
AMICO LAB, INC.
510(k) number
K842526
Product code
LOO  
Decision
Substantially Equivalent (SESE)
Decision date
1984-08-28
Date received
1984-06-28
Regulation
866.3870
Classification name
Reagent, Leishmanii Serological
Medical specialty
Microbiology
Review panel
Immunology
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 LOO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K023483KALAZAR DETECTInbios Intl., Inc.2003-05-06

Legacy Summary#

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FDA Review#

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