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

Centrifuge, Blood-Bank For In Vitro Diagnostic Use

21 CFR 864.9275 / Hematology
FDA source (opens on fda.gov)

KSO is the FDA product code for Centrifuge, Blood-Bank For In Vitro Diagnostic Use, a class I device type, regulated under 21 CFR 864.9275. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
KSO
Device name
Centrifuge, Blood-Bank For In Vitro Diagnostic Use
Regulation
21 CFR 864.9275
Device class
Class I
Review panel
Hematology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code KSO

By decision year
1 clearance under product code KSO with a decision year between 1978 and 1978, 1978 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KSO by decision year
YearClearances
19781

Applicants with the most clearances

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

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 18 companies shown, in name order