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510(k) K870089

Device
IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT
Applicant
MICROSCAN DIV. BAXTER HEALTHCARE CORP.
510(k) number
K870089
Product code
GTJ  
Decision
Substantially Equivalent (SESE)
Decision date
1987-03-17
Date received
1987-01-09
Regulation
866.3390
Classification name
Antisera, All Groups, N. Meningitidis
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
LORRAINE WEAVER
Address
2040 Enterprise Blvd. West Sacramento CA US 95691 95691

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Legacy Summary#

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FDA Review#

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