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

Bottle, Roller, Tissue Culture

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

KJC is the FDA product code for Bottle, Roller, Tissue Culture, a class I device type, regulated under 21 CFR 864.2240. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KJC
Device name
Bottle, Roller, Tissue 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
3
Ingested recalls
0

Clearances, product code KJC

By decision year
3 clearances under product code KJC with a decision year between 1979 and 1988, 1979 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KJC by decision year
YearClearances
19791
19871
19881

Applicants with the most clearances

Product code KJC
Applicants holding the most 510(k) clearances under product code KJC
ApplicantClearances
Dynatech Laboratories, Inc.1
In Vitro Scientific Products1
Motil Plastics, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 18 companies shown, in name order