510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
MZUClass II

System, Test, Sodium, Enzymatic Method

21 CFR 862.1665 / Clinical Chemistry
FDA source (opens on fda.gov)

MZU is the FDA product code for System, Test, Sodium, Enzymatic Method, a class II device type, regulated under 21 CFR 862.1665. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
MZU
Device name
System, Test, Sodium, Enzymatic Method
Regulation
21 CFR 862.1665
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
2
Ingested recalls
0

Clearances, product code MZU

By decision year
2 clearances under product code MZU with a decision year between 2004 and 2008, 2004 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code MZU by decision year
YearClearances
20041
20081

Applicants with the most clearances

Product code MZU
Applicants holding the most 510(k) clearances under product code MZU
ApplicantClearances
Diazyme Laboratories, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code