510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
KZJClass I

Device, Gas Generating

21 CFR 866.2580 / Microbiology
FDA source (opens on fda.gov)

KZJ is the FDA product code for Device, Gas Generating, a class I device type, regulated under 21 CFR 866.2580. As of , FDA records hold 18 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
KZJ
Device name
Device, Gas Generating
Regulation
21 CFR 866.2580
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
18
Ingested recalls
4

Clearances, product code KZJ

By decision year
18 clearances under product code KZJ with a decision year between 1980 and 1988, 1980 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code KZJ by decision year
YearClearances
19804
19811
19822
19831
19841
19853
19861
19873
19882

Applicants with the most clearances

Product code KZJ
Applicants holding the most 510(k) clearances under product code KZJ
ApplicantClearances
BD Becton Dickinson Vacutainer Systems Preanalytic8
Fairleigh Dickinson Laboratories, Inc.2
Marion Laboratories, Inc.2
Oxoid U.S.A., Inc.2
Difco Laboratories, Inc.1
Flow Laboratories, Inc.1
Miles Laboratories, Inc.1
Scott Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 18 companies shown, in name order