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

Stainer, Tissue, Automated

21 CFR 864.3800 / Pathology
FDA source (opens on fda.gov)

KEY is the FDA product code for Stainer, Tissue, Automated, a class I device type, regulated under 21 CFR 864.3800. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and 5 recalls.

Classification record

Product code
KEY
Device name
Stainer, Tissue, Automated
Regulation
21 CFR 864.3800
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
1
Ingested recalls
5

Clearances, product code KEY

By decision year
1 clearance under product code KEY with a decision year between 1977 and 1977, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KEY by decision year
YearClearances
19771

Applicants with the most clearances

Product code KEY
Applicants holding the most 510(k) clearances under product code KEY
ApplicantClearances
Honeywell, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order