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

Stains, Dye Powder

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

LEF is the FDA product code for Stains, Dye Powder, 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
LEF
Device name
Stains, Dye Powder
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 LEF

By decision year
1 clearance under product code LEF with a decision year between 1987 and 1987, 1987 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LEF by decision year
YearClearances
19871

Applicants with the most clearances

Product code LEF
Applicants holding the most 510(k) clearances under product code LEF
ApplicantClearances
Sigma Chemical Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code