Centria-Set Type D(Anti-Sheep/Goat)

Q: What is the product code of K792637?

The FDA product code is KTS – Second Antibody (Species Specific Anti-Animal Gamma Globulin), a Class II (moderate risk) device regulated under 21 CFR 866.5510.

FDA 510(k) K792637 · Union Carbide Corp.

Substantially Equivalent

510(k) numberK792637

Submission

Device name: Centria-Set Type D(Anti-Sheep/Goat)
Applicant: Union Carbide Corp.
Mchenry, IL, US
Received: December 20, 1979
Decision date: January 11, 1980
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: KTS – Second Antibody (Species Specific Anti-Animal Gamma Globulin)
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.5510
Specialty: Immunology

Other 510(k)s with product code KTS

510(k)	Device	Applicant	Decision
K813508	Sac-CelKTS · Traditional	Burroughs Wellcome Co.	12/29/1981SE
K792636	Centria Radioimmunoassay SeparationKTS · Traditional	Union Carbide Corp.	01/11/1980SE
K781070	Second AntibodyKTS · Traditional	Pcl-Ria, Inc.	08/10/1978SE

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Questions and answers

When was Centria-Set Type D(Anti-Sheep/Goat) cleared by the FDA?

Centria-Set Type D(Anti-Sheep/Goat) (K792637) received a 510(k) decision of Substantially Equivalent on January 11, 1980, 22 days after the submission was received.

What is the product code of K792637?

The FDA product code is KTS – Second Antibody (Species Specific Anti-Animal Gamma Globulin), a Class II (moderate risk) device regulated under 21 CFR 866.5510.