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

Refrigerator, Freezer, Blood Storage

21 CFR 864.9700 / Hematology
FDA source (opens on fda.gov)

KSE is the FDA product code for Refrigerator, Freezer, Blood Storage, a class II device type, regulated under 21 CFR 864.9700. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KSE
Device name
Refrigerator, Freezer, Blood Storage
Regulation
21 CFR 864.9700
Device class
Class II
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
4
Ingested recalls
0

Clearances, product code KSE

By decision year
4 clearances under product code KSE with a decision year between 1980 and 1988, 1980 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code KSE by decision year
YearClearances
19802
19811
19881

Applicants with the most clearances

Product code KSE
Applicants holding the most 510(k) clearances under product code KSE
ApplicantClearances
Harris Mfg. Co.1
Liquid Crystal Products, Inc.1
Marion Laboratories, Inc.1
Separation Science Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 38 companies shown, in name order