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

Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator

21 CFR 876.5820 / Gastroenterology, Urology
FDA source (opens on fda.gov)

NTZ is the FDA product code for Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator, a class II device type, regulated under 21 CFR 876.5820. FDA's definition for this code reads: "Device provides semiquantitative indications of ph, bicarbonate ions, and glucose in the final bicarbonate dialysate". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
NTZ
Device name
Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator
FDA definition
Device provides semiquantitative indications of ph, bicarbonate ions, and glucose in the final bicarbonate dialysate.
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code NTZ

By decision year
1 clearance under product code NTZ with a decision year between 2005 and 2005, 2005 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NTZ by decision year
YearClearances
20051

Applicants with the most clearances

Product code NTZ
Applicants holding the most 510(k) clearances under product code NTZ
ApplicantClearances
Serim Research Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code NTZ.