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

Reader, Zone, Automated

21 CFR 866.2850 / Microbiology
FDA source (opens on fda.gov)

KZK is the FDA product code for Reader, Zone, Automated, a class I device type, regulated under 21 CFR 866.2850. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KZK
Device name
Reader, Zone, Automated
Regulation
21 CFR 866.2850
Device class
Class I
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
3
Ingested recalls
0

Clearances, product code KZK

By decision year
3 clearances under product code KZK with a decision year between 1994 and 1999, 1994 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code KZK by decision year
YearClearances
19942
19991

Applicants with the most clearances

Product code KZK
Applicants holding the most 510(k) clearances under product code KZK
ApplicantClearances
Giles Scientific Inc2
Intelligence Artificielle Applications1

Companies listing this code with FDA

Companies whose registered establishments list this code