FDA.reportPublic FDA data

510(k) K821949

Device
Ortho* Alternative Pathway Compl. Test
Applicant
ORTHO DIAGNOSTIC SYSTEMS, INC.
510(k) number
K821949
Product code
DAK
Decision
Substantially Equivalent (SESE)
Decision date
1982-08-27
Date received
1982-06-30
Regulation
866.5240
Classification name
Complement C1q, Antigen, Antiserum, Control
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
125 Mark Ave. Carpinteria CA US 93013 93013

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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