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

Kit, Serological, Positive Control

21 CFR 862.1660 / Clinical Chemistry
FDA source (opens on fda.gov)

MJX is the FDA product code for Kit, Serological, Positive Control, a class I device type, regulated under 21 CFR 862.1660. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
MJX
Device name
Kit, Serological, Positive Control
Regulation
21 CFR 862.1660
Device class
Class I
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
7
Ingested recalls
1

Clearances, product code MJX

By decision year
7 clearances under product code MJX with a decision year between 1993 and 2010, 1997 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code MJX by decision year
YearClearances
19931
19941
19973
20031
20101

Applicants with the most clearances

Product code MJX
Applicants holding the most 510(k) clearances under product code MJX
ApplicantClearances
Aalto Scientific Ltd.1
Boston Biomedica, Inc.1
Ortho-Clinical Diagnostics, Inc.1
Pb Diagnostic Systems, Inc.1
Pb Diagnostics, Inc.1
Scantibodies Laboratory Inc.1
Simplicity Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code