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510(k) K911417

Device
ICON STREP B IMMUNOENZYMETRIC ASSAY
Applicant
HYBRITECH, INC.
510(k) number
K911417
Product code
GTZ  
Decision
Substantially Equivalent (SESE)
Decision date
1991-07-24
Date received
1991-04-01
Regulation
866.3740
Classification name
Antisera, All Groups, Streptococcus Spp.
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JOANNE MARTINIS
Address
11095 Torreyana Rd. P.O. Box 269006 San Diego CA US 92126 92126

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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