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510(k) K811445

Device
KALLESTAD R QUANTIPLATE ALT. PATHWAY T.
Applicant
KALLESTAD LABORATORIES, INC.
510(k) number
K811445
Product code
DHL  
Decision
Substantially Equivalent (SESE)
Decision date
1981-06-24
Date received
1981-05-22
Regulation
866.4100
Classification name
Protein, Complement, Antigen, Antiserum, Control
Medical specialty
Immunology
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 DHL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K870351EZ COMPLEMENT REAGENTS, 78N2212Diamedix Corp.1987-03-13
K811433SCRIPPSERA COMPLEMENT CONTROL SERAScripps-Miles, Inc.1981-06-16
K770866RABBIT COMPLEMENTCedarlake Labs , Ltd.1977-06-03

Legacy Summary#

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FDA Review#

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