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

Automated Colony Counter

21 CFR 866.2170 / Microbiology
FDA source (opens on fda.gov)

KZB is the FDA product code for Automated Colony Counter, a class I device type, regulated under 21 CFR 866.2170. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and 2 recalls.

Classification record

Product code
KZB
Device name
Automated Colony Counter
Regulation
21 CFR 866.2170
Device class
Class I
Review panel
Microbiology
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
2

Clearances, product code KZB

By decision year
1 clearance under product code KZB with a decision year between 1989 and 1989, 1989 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KZB by decision year
YearClearances
19891

Applicants with the most clearances

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

Companies listing this code with FDA

Companies whose registered establishments list this code