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

System, Blood Collection, Vacuum-Assisted, Manual

21 CFR 864.9125 / Hematology
FDA source (opens on fda.gov)

KST is the FDA product code for System, Blood Collection, Vacuum-Assisted, Manual, a class I device type, regulated under 21 CFR 864.9125. As of , FDA records hold no 510(k) clearances under this code and 4 recalls.

Classification record

Product code
KST
Device name
System, Blood Collection, Vacuum-Assisted, Manual
Regulation
21 CFR 864.9125
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
0
Ingested recalls
4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 78 companies shown, in name order