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510(k) K813508

Device
SAC-CEL
Applicant
BURROUGHS WELLCOME CO.
510(k) number
K813508
Product code
KTS  
Decision
Substantially Equivalent (SESE)
Decision date
1981-12-29
Date received
1981-12-15
Regulation
866.5510
Classification name
Second Antibody (species Specific Anti-animal Gamma Globulin)
Medical specialty
Immunology
Review panel
Pathology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

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

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KTS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K792636CENTRIA RADIOIMMUNOASSAY SEPARATIONUnion Carbide Corp.1980-01-11
K792637CENTRIA-SET TYPE D(ANTI-SHEEP/GOAT)Union Carbide Corp.1980-01-11
K781070SECOND ANTIBODYPcl-Ria, Inc.1978-08-10

Legacy Summary#

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FDA Review#

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