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

Formulations, Paraffin, All

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

KEO is the FDA product code for Formulations, Paraffin, All, a class I device type, regulated under 21 CFR 864.4010. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
KEO
Device name
Formulations, Paraffin, All
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
11
Ingested recalls
3

Clearances, product code KEO

By decision year
11 clearances under product code KEO with a decision year between 1976 and 1989, 1981 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code KEO by decision year
YearClearances
19761
19813
19832
19841
19863
19891

Applicants with the most clearances

Product code KEO
Applicants holding the most 510(k) clearances under product code KEO
ApplicantClearances
Surgipath Medical Industries, Inc.3
American Scientific Products1
E.I. Dupont de Nemours & Co., Inc.1
Erie Scientific Co.1
Miles Laboratories, Inc.1
Richard-Allan Medical Ind., Inc.1
Sherwood Medical Co.1
Stephens Scientific1
Technicon Instruments Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 25 companies shown, in name order