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510(k) K843122

Device
RESOLVE-CSF
Applicant
ISOLAB, INC.
510(k) number
K843122
Product code
DFI  
Decision
Substantially Equivalent (SESE)
Decision date
1984-11-30
Date received
1984-08-08
Regulation
866.5860
Classification name
Total Spinal-fluid, Antigen, Antiserum, Control
Medical specialty
Immunology
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
LOREN F HAZELWOOD
Address
Drawer 4350 Akron OH US 44321 44321

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DFI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K854190CANTROL SPINAL FLUID CONTROLCanyon Diagnostics, Inc.1985-11-25
K840974SOMAS HUMAN SPINAL FLUID CONTROLSomas Medical Industries, Inc.1984-04-05
K832821FIAX IGG TESTIntl. Diagnostic Technology1983-10-14

Legacy Summary#

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FDA Review#

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