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

Stains, Dye Solution

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

LEE is the FDA product code for Stains, Dye Solution, 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 no recalls.

Classification record

Product code
LEE
Device name
Stains, Dye Solution
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
0

Clearances, product code LEE

By decision year
1 clearance under product code LEE with a decision year between 1982 and 1982, 1982 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LEE by decision year
YearClearances
19821

Applicants with the most clearances

Product code LEE
Applicants holding the most 510(k) clearances under product code LEE
ApplicantClearances
V-Tech, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 32 companies shown, in name order