510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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KSNClass II

Centrifuge, Cell-Washing, Automated For Immuno-Hematology

21 CFR 864.9285 / Hematology
FDA source (opens on fda.gov)

KSN is the FDA product code for Centrifuge, Cell-Washing, Automated For Immuno-Hematology, a class II device type, regulated under 21 CFR 864.9285. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
KSN
Device name
Centrifuge, Cell-Washing, Automated For Immuno-Hematology
Regulation
21 CFR 864.9285
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code KSN

By decision year
1 clearance under product code KSN with a decision year between 1979 and 1979, 1979 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KSN by decision year
YearClearances
19791

Applicants with the most clearances

Product code KSN
Applicants holding the most 510(k) clearances under product code KSN
ApplicantClearances
Dade, Baxter Travenol Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code