Product code KSN— Hematology

IMMU-TEK AUTOMATIC CENTRIFUGE

Classification name: Centrifuge, Cell-Washing, Automated For Immuno-Hematology
Device class: Class 2
Regulation: 21 CFR 864.9285
Advisory panel: Hematology
Total cleared: 1
First cleared: 1979-05-23
Most recent: 1979-05-23

Market context for product code KSN

FDA has cleared 1 device under product code KSN, all in 1979, filed by 1 applicant company. 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.

Top applicants under product code KSN

Dade, Baxter Travenol Diagnostics, Inc.1 clearance

Recent clearances under product code KSN

K790767 — IMMU-TEK AUTOMATIC CENTRIFUGEDade, Baxter Travenol Diagnostics, Inc.·1979-05-23

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