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

System, Test, Automated Blood Grouping And Antibody

21 CFR 864.9175 / Hematology
FDA source (opens on fda.gov)

KSZ is the FDA product code for System, Test, Automated Blood Grouping And Antibody, a class II device type, regulated under 21 CFR 864.9175. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KSZ
Device name
System, Test, Automated Blood Grouping And Antibody
Regulation
21 CFR 864.9175
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
4
Ingested recalls
0

Clearances, product code KSZ

By decision year
4 clearances under product code KSZ with a decision year between 1977 and 1981, 1977 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code KSZ by decision year
YearClearances
19772
19791
19811

Applicants with the most clearances

Product code KSZ
Applicants holding the most 510(k) clearances under product code KSZ
ApplicantClearances
Technicon Instruments Corp.2
BD Becton Dickinson Vacutainer Systems Preanalytic1
Nordisk Infuser System1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 26 companies shown, in name order