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

Analyzer, Heparin, Automated

21 CFR 864.5680 / Hematology
FDA source (opens on fda.gov)

JOX is the FDA product code for Analyzer, Heparin, Automated, a class II device type, regulated under 21 CFR 864.5680. As of , FDA records hold 15 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
JOX
Device name
Analyzer, Heparin, Automated
Regulation
21 CFR 864.5680
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
15
Ingested recalls
2

Clearances, product code JOX

By decision year
15 clearances under product code JOX with a decision year between 1980 and 2011, 2004 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code JOX by decision year
YearClearances
19801
19821
19831
19841
19851
19891
19911
19921
20001
20042
20051
20102
20111

Applicants with the most clearances

Product code JOX
Applicants holding the most 510(k) clearances under product code JOX
ApplicantClearances
Hemotec, Inc.5
Medtronic, Inc.5
Cardiovascular Diagnostics, Inc.1
Hemotech, Inc.1
Medtronic Hemotec, Inc.1
Medtronic Perfusion Systems1
Streck Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code