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510(k) K781607

Device
STREP-TEX
Applicant
BURROUGHS WELLCOME CO.
510(k) number
K781607
Product code
GTZ  
Decision
Substantially Equivalent (SESE)
Decision date
1978-10-17
Date received
1978-09-18
Regulation
866.3740
Classification name
Antisera, All Groups, Streptococcus Spp.
Medical specialty
Microbiology
Review panel
Immunology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

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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