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

Methylene Blue, Tissue Stain

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

KFC is the FDA product code for Methylene Blue, Tissue Stain, a class I device type, regulated under 21 CFR 864.1850. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KFC
Device name
Methylene Blue, Tissue Stain
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
7
Ingested recalls
0

Clearances, product code KFC

By decision year
7 clearances under product code KFC with a decision year between 1977 and 1988, 1984 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code KFC by decision year
YearClearances
19771
19831
19844
19881

Applicants with the most clearances

Product code KFC
Applicants holding the most 510(k) clearances under product code KFC
ApplicantClearances
E K Ind., Inc.2
Corning Medical & Scientific1
Difco Laboratories, Inc.1
Flaitron Laboratories, Inc.1
Reagent Laboratory, Inc.1
Sigma Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 18 companies shown, in name order