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

System, Suspension, Cell Culture

21 CFR 864.2240 / Hematology
FDA source (opens on fda.gov)

KJF is the FDA product code for System, Suspension, Cell Culture, a class I device type, regulated under 21 CFR 864.2240. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KJF
Device name
System, Suspension, Cell Culture
Regulation
21 CFR 864.2240
Device class
Class I
Review panel
Hematology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
4
Ingested recalls
0

Clearances, product code KJF

By decision year
4 clearances under product code KJF with a decision year between 1978 and 1989, 1989 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code KJF by decision year
YearClearances
19781
19881
19892

Applicants with the most clearances

Product code KJF
Applicants holding the most 510(k) clearances under product code KJF
ApplicantClearances
Amicon, Inc.1
Baxter Healthcare Corporation1
Biological Rescue Products, Inc.1
Dynatech Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 17 companies shown, in name order