Product code KTS

Device name: Second Antibody (Species Specific Anti-Animal Gamma Globulin)
Medical specialty: Immunology
Device class: 2
Regulation number: 866.5510
Review panel: IM
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: Y
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K813508	SAC-CEL	Burroughs Wellcome Co.	1981-12-29
K792636	CENTRIA RADIOIMMUNOASSAY SEPARATION	Union Carbide Corp.	1980-01-11
K792637	CENTRIA-SET TYPE D(ANTI-SHEEP/GOAT)	Union Carbide Corp.	1980-01-11
K781070	SECOND ANTIBODY	Pcl-Ria, Inc.	1978-08-10