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

Kit, Direct Antigen, Positive Control

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

MJZ is the FDA product code for Kit, Direct Antigen, Positive Control, a class I device type, regulated under 21 CFR 862.1660. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
MJZ
Device name
Kit, Direct Antigen, 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
3
Ingested recalls
0

Clearances, product code MJZ

By decision year
3 clearances under product code MJZ with a decision year between 1997 and 2009, 1997 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code MJZ by decision year
YearClearances
19972
20091

Applicants with the most clearances

Product code MJZ
Applicants holding the most 510(k) clearances under product code MJZ
ApplicantClearances
Abbott Diagnostics1
Binax, Inc.1
Blackhawk Biosystems, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code