RESOLVE-CSF

Total Spinal-fluid, Antigen, Antiserum, Control

ISOLAB, INC.

The following data is part of a premarket notification filed by Isolab, Inc. with the FDA for Resolve-csf.

Pre-market Notification Details

Device IDK843122
510k NumberK843122
Device Name:RESOLVE-CSF
ClassificationTotal Spinal-fluid, Antigen, Antiserum, Control
Applicant ISOLAB, INC. DRAWER 4350 Akron,  OH  44321
ContactLoren F Hazelwood
CorrespondentLoren F Hazelwood
ISOLAB, INC. DRAWER 4350 Akron,  OH  44321
Product CodeDFI  
CFR Regulation Number866.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-08-08
Decision Date1984-11-30

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