510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
KJKClass I

Auramine O

21 CFR 864.1850 / Hematology
FDA source (opens on fda.gov)

KJK is the FDA product code for Auramine O, a class I device type, regulated under 21 CFR 864.1850. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KJK
Device name
Auramine O
Regulation
21 CFR 864.1850
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
2
Ingested recalls
0

Clearances, product code KJK

By decision year
2 clearances under product code KJK with a decision year between 1981 and 1985, 1981 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KJK by decision year
YearClearances
19811
19851

Applicants with the most clearances

Product code KJK
Applicants holding the most 510(k) clearances under product code KJK
ApplicantClearances
Advanced Medical Technology, Inc.1
Carr-Scarborough Microbiologicals, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code