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

Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free)

21 CFR 862.3350 / Clinical Toxicology
FDA source (opens on fda.gov)

MOJ is the FDA product code for Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free), a class II device type, regulated under 21 CFR 862.3350. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
MOJ
Device name
Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free)
Regulation
21 CFR 862.3350
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
3
Ingested recalls
0

Clearances, product code MOJ

By decision year
3 clearances under product code MOJ with a decision year between 1995 and 2023, 1995 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code MOJ by decision year
YearClearances
19952
20231

Applicants with the most clearances

Product code MOJ
Applicants holding the most 510(k) clearances under product code MOJ
ApplicantClearances
Abbott Medical1
Roche Diagnostic Systems, Inc.1
Roche Diagnostics GmbH1

Companies listing this code with FDA

Companies whose registered establishments list this code