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

Container, Embedding

21 CFR 864.3010 / Pathology
FDA source (opens on fda.gov)

KER is the FDA product code for Container, Embedding, a class I device type, regulated under 21 CFR 864.3010. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KER
Device name
Container, Embedding
Regulation
21 CFR 864.3010
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 KER

By decision year
5 clearances under product code KER with a decision year between 1977 and 1983, 1983 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code KER by decision year
YearClearances
19771
19834

Applicants with the most clearances

Product code KER
Applicants holding the most 510(k) clearances under product code KER
ApplicantClearances
Polymer Technology Corp.2
Surgipath Medical Industries, Inc.2
Sherwood Medical Industries1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 28 companies shown, in name order