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

Chamber, Slide Culture

21 CFR 864.2240 / Hematology
FDA source (opens on fda.gov)

KIY is the FDA product code for Chamber, Slide Culture, a class I device type, regulated under 21 CFR 864.2240. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
KIY
Device name
Chamber, Slide Culture
Regulation
21 CFR 864.2240
Device class
Class I
Review panel
Hematology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code KIY

By decision year
1 clearance under product code KIY with a decision year between 1978 and 1978, 1978 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KIY by decision year
YearClearances
19781

Applicants with the most clearances

Product code KIY
Applicants holding the most 510(k) clearances under product code KIY
ApplicantClearances
Zeus Scientific LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code