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

Agent, Clearing

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

KEM is the FDA product code for Agent, Clearing, a class I device type, regulated under 21 CFR 864.4010. As of , FDA records hold 15 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KEM
Device name
Agent, Clearing
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
15
Ingested recalls
0

Clearances, product code KEM

By decision year
15 clearances under product code KEM with a decision year between 1981 and 1988, 1981 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code KEM by decision year
YearClearances
19813
19821
19833
19842
19852
19862
19871
19881

Applicants with the most clearances

Product code KEM
Applicants holding the most 510(k) clearances under product code KEM
ApplicantClearances
Richard-Allan Medical Ind., Inc.5
Anatech, Ltd.2
Lerner Laboratories, Inc.2
Chem Pharm, Inc.1
E K Ind., Inc.1
Helena Laboratories, Corp.1
Pmp Industries1
Stephens Scientific1
Surgipath Medical Industries, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 31 companies shown, in name order