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

Sudan Iv

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

KKK is the FDA product code for Sudan Iv, a class I device type, regulated under 21 CFR 864.1850. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and 2 recalls.

Classification record

Product code
KKK
Device name
Sudan Iv
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
1
Ingested recalls
2

Clearances, product code KKK

By decision year
1 clearance under product code KKK with a decision year between 1984 and 1984, 1984 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KKK by decision year
YearClearances
19841

Applicants with the most clearances

Product code KKK
Applicants holding the most 510(k) clearances under product code KKK
ApplicantClearances
E K Ind., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code