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510(k) K860778

Device
TANDEM ICON STREP A IMMUNOENZYMETRIC ASSAY KIT
Applicant
HYBRITECH, INC.
510(k) number
K860778
Product code
GTZ  
Decision
Substantially Equivalent (SESE)
Decision date
1986-04-04
Date received
1986-03-03
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
BRUNI, PH.D.
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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