Product code KTS— Immunology

CENTRIA RADIOIMMUNOASSAY SEPARATION

Classification name: Second Antibody (Species Specific Anti-Animal Gamma Globulin)
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Total cleared: 4
First cleared: 1978-08-10
Most recent: 1981-12-29

Market context for product code KTS

FDA has cleared 4 devices under product code KTS between 1978 and 1981, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

19811 clearance
19802 clearances
19781 clearance

Top applicants under product code KTS

Union Carbide Corp.2 clearances
Pcl-Ria, Inc.1 clearance
Burroughs Wellcome Co.1 clearance

Recent clearances under product code KTS

K813508 — SAC-CELBurroughs Wellcome Co.·1981-12-29
K792636 — CENTRIA RADIOIMMUNOASSAY SEPARATIONUnion Carbide Corp.·1980-01-11
K792637 — CENTRIA-SET TYPE D(ANTI-SHEEP/GOAT)Union Carbide Corp.·1980-01-11
K781070 — SECOND ANTIBODYPcl-Ria, Inc.·1978-08-10

Data sourced from openFDA. This site is unofficial and independent of the FDA.