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

Cytokeratins

21 CFR 866.5550 / Immunology
FDA source (opens on fda.gov)

LYE is the FDA product code for Cytokeratins, a class II device type, regulated under 21 CFR 866.5550. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LYE
Device name
Cytokeratins
Regulation
21 CFR 866.5550
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
2
Ingested recalls
0

Clearances, product code LYE

By decision year
2 clearances under product code LYE with a decision year between 1988 and 1988, 1988 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code LYE by decision year
YearClearances
19882

Applicants with the most clearances

Product code LYE
Applicants holding the most 510(k) clearances under product code LYE
ApplicantClearances
BD Becton Dickinson Vacutainer Systems Preanalytic1
Triton Biosciences, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code