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

Device, Warming. Blood And Plasma

21 CFR 864.9205 / Hematology
FDA source (opens on fda.gov)

KZL is the FDA product code for Device, Warming. Blood And Plasma, a class II device type, regulated under 21 CFR 864.9205. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KZL
Device name
Device, Warming. Blood And Plasma
Regulation
21 CFR 864.9205
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 KZL

By decision year
4 clearances under product code KZL with a decision year between 1979 and 1982, 1979 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KZL by decision year
YearClearances
19791
19801
19811
19821

Applicants with the most clearances

Product code KZL
Applicants holding the most 510(k) clearances under product code KZL
ApplicantClearances
Cryosan, Inc.2
Chroma Products, Inc.1
Vickers America Medical Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code