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

Mounting Media

21 CFR 864.4010 / Pathology
FDA source (opens on fda.gov)

LEB is the FDA product code for Mounting Media, a class I device type, regulated under 21 CFR 864.4010. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LEB
Device name
Mounting Media
Regulation
21 CFR 864.4010
Device class
Class I
Review panel
Pathology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
5
Ingested recalls
0

Clearances, product code LEB

By decision year
5 clearances under product code LEB with a decision year between 1976 and 1984, 1981 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code LEB by decision year
YearClearances
19761
19812
19821
19841

Applicants with the most clearances

Product code LEB
Applicants holding the most 510(k) clearances under product code LEB
ApplicantClearances
American Scientific Products1
Anatech, Ltd.1
I M, Inc.1
Microbiological Research Corp.1
Richard-Allan Medical Ind., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 25 companies shown, in name order