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

Test, System, Potassium, Enzymatic Method

21 CFR 862.1600 / Clinical Chemistry
FDA source (opens on fda.gov)

MZV is the FDA product code for Test, System, Potassium, Enzymatic Method, a class II device type, regulated under 21 CFR 862.1600. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
MZV
Device name
Test, System, Potassium, Enzymatic Method
Regulation
21 CFR 862.1600
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
4
Ingested recalls
0

Clearances, product code MZV

By decision year
4 clearances under product code MZV with a decision year between 2004 and 2021, 2004 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code MZV by decision year
YearClearances
20041
20061
20091
20211

Applicants with the most clearances

Product code MZV
Applicants holding the most 510(k) clearances under product code MZV
ApplicantClearances
Diazyme Laboratories, Inc.3
Abaxis Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code