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

Test, Urea (Breath Or Blood)

21 CFR 866.3110 / Microbiology
FDA source (opens on fda.gov)

MSQ is the FDA product code for Test, Urea (Breath Or Blood), a class I device type, regulated under 21 CFR 866.3110. As of , FDA records hold 17 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
MSQ
Device name
Test, Urea (Breath Or Blood)
Regulation
21 CFR 866.3110
Device class
Class I
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
17
Ingested recalls
2

Clearances, product code MSQ

By decision year
17 clearances under product code MSQ with a decision year between 1997 and 2022, 2022 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code MSQ by decision year
YearClearances
19971
19981
19991
20001
20011
20021
20041
20102
20131
20161
20182
20201
20223

Applicants with the most clearances

Product code MSQ
Applicants holding the most 510(k) clearances under product code MSQ
ApplicantClearances
Meridian Bioscience Israel Ltd.8
Meretek Diagnostics, Inc.2
Otsuka Pharmaceutical Co., Ltd.2
Alimenterics, Inc.1
Hema Metrics, LLC1
Meretek1
Metabolic Solutions, Inc.1
Oridion Medical 1987 Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code