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510(k) K781070

Device
SECOND ANTIBODY
Applicant
PCL-RIA, INC.
510(k) number
K781070
Product code
KTS  
Decision
Substantially Equivalent (SESE)
Decision date
1978-08-10
Date received
1978-06-26
Regulation
866.5510
Classification name
Second Antibody (species Specific Anti-animal Gamma Globulin)
Medical specialty
Immunology
Review panel
Immunology
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
K813508SAC-CELBurroughs Wellcome Co.1981-12-29
K792636CENTRIA RADIOIMMUNOASSAY SEPARATIONUnion Carbide Corp.1980-01-11
K792637CENTRIA-SET TYPE D(ANTI-SHEEP/GOAT)Union Carbide Corp.1980-01-11

Legacy Summary#

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FDA Review#

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