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
JXOClass II

Enzyme Immunoassay, Cocaine

21 CFR 862.3250 / Clinical Toxicology
FDA source (opens on fda.gov)

JXO is the FDA product code for Enzyme Immunoassay, Cocaine, a class II device type, regulated under 21 CFR 862.3250. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JXO
Device name
Enzyme Immunoassay, Cocaine
Regulation
21 CFR 862.3250
Device class
Class II
Review panel
Clinical Toxicology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
6
Ingested recalls
0

Clearances, product code JXO

By decision year
6 clearances under product code JXO with a decision year between 1991 and 2021, 1992 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code JXO by decision year
YearClearances
19911
19923
20121
20211

Applicants with the most clearances

Product code JXO
Applicants holding the most 510(k) clearances under product code JXO
ApplicantClearances
Psychemedics Corp.2
Solarcare Technologies Corp,Inc.2
Instrumentation Laboratory Co.1
Serex, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code