FDA.reportPublic FDA data

510(k) K951822

Device
Ebna Enzyme Immunoassay Kit
Applicant
GRANBIO, INC.
510(k) number
K951822
Product code
LLM
Decision
Substantially Equivalent (SESE)
Decision date
1996-02-15
Date received
1995-04-20
Regulation
866.3235
Classification name
Test, Antigen, Nuclear, Epstein-Barr Virus
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DAVID J GRANLUND
Address
38660 De Portola Rd. P.O. Box 892140 Temecula CA US 92589 92589

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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