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

System, Test, Tumor Marker, Monitoring, Bladder

21 CFR 866.6010 / Immunology
FDA source (opens on fda.gov)

MMW is the FDA product code for System, Test, Tumor Marker, Monitoring, Bladder, a class II device type, regulated under 21 CFR 866.6010. As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
MMW
Device name
System, Test, Tumor Marker, Monitoring, Bladder
Regulation
21 CFR 866.6010
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
9
Ingested recalls
1

Clearances, product code MMW

By decision year
9 clearances under product code MMW with a decision year between 1997 and 2023, 1997 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code MMW by decision year
YearClearances
19972
19982
20011
20022
20041
20231

Applicants with the most clearances

Product code MMW
Applicants holding the most 510(k) clearances under product code MMW
ApplicantClearances
Bard Diagnostic Sciences,Inc.3
Vysis3
Matritech, Inc.1
Nucleix Ltd.1
Perimmune, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code