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

Processor, Tissue, Automated

21 CFR 864.3875 / Pathology
FDA source (opens on fda.gov)

IEO is the FDA product code for Processor, Tissue, Automated, a class I device type, regulated under 21 CFR 864.3875. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and 11 recalls.

Classification record

Product code
IEO
Device name
Processor, Tissue, Automated
Regulation
21 CFR 864.3875
Device class
Class I
Review panel
Pathology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
12
Ingested recalls
11

Clearances, product code IEO

By decision year
12 clearances under product code IEO with a decision year between 1977 and 1992, 1977 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code IEO by decision year
YearClearances
19772
19802
19831
19842
19852
19882
19921

Applicants with the most clearances

Product code IEO
Applicants holding the most 510(k) clearances under product code IEO
ApplicantClearances
Innovative Medical Systems, Inc.5
Miles Laboratories, Inc.4
Lkb Instruments, Inc.1
Sakura Finetek USA Inc1
Technicon Instruments Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 31 companies shown, in name order