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

Adhesive, Albumin-Based

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

KEL is the FDA product code for Adhesive, Albumin-Based, a class I device type, regulated under 21 CFR 864.4010. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KEL
Device name
Adhesive, Albumin-Based
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
2
Ingested recalls
0

Clearances, product code KEL

By decision year
2 clearances under product code KEL with a decision year between 1988 and 1989, 1988 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KEL by decision year
YearClearances
19881
19891

Applicants with the most clearances

Product code KEL
Applicants holding the most 510(k) clearances under product code KEL
ApplicantClearances
Alpha-Tec Systems, Inc.1
Stat Path1

Companies listing this code with FDA

Companies whose registered establishments list this code