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

Enzyme Immunoassay, Propoxyphene

21 CFR 862.3700 / Clinical Toxicology
FDA source (opens on fda.gov)

JXN is the FDA product code for Enzyme Immunoassay, Propoxyphene, a class II device type, regulated under 21 CFR 862.3700. As of , FDA records hold 22 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
JXN
Device name
Enzyme Immunoassay, Propoxyphene
Regulation
21 CFR 862.3700
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
22
Ingested recalls
2

Clearances, product code JXN

By decision year
22 clearances under product code JXN with a decision year between 1985 and 2015, 2002 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code JXN by decision year
YearClearances
19851
19871
19911
19921
19942
19952
19961
19981
20001
20011
20023
20032
20041
20051
20111
20131
20151

Applicants with the most clearances

Product code JXN
Applicants holding the most 510(k) clearances under product code JXN
ApplicantClearances
Abbott Medical2
Roche Diagnostic Systems, Inc.2
Syva Co.2
Syva Co.2
Acon Laboratories, Inc.1
Alfa Scientific Designs, Inc.1
American Bio Medica Corp.1
Beckman Instruments, Inc.1
Branan Medical Corp.1
Diagnostic Reagents, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 50 companies shown, in name order