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

Filters, Cell Collection, Tissue Processing

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

KET is the FDA product code for Filters, Cell Collection, Tissue Processing, 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
KET
Device name
Filters, Cell Collection, Tissue Processing
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 KET

By decision year
5 clearances under product code KET with a decision year between 1980 and 1988, 1980 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KET by decision year
YearClearances
19801
19841
19851
19871
19881

Applicants with the most clearances

Product code KET
Applicants holding the most 510(k) clearances under product code KET
ApplicantClearances
Corning Medical & Scientific3
Poretics Corp.1
Procter & Gamble Mfg. Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 55 companies shown, in name order