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

Test, Nitrite, Urinary, Non-Quantitative, Over The Counter

21 CFR 862.1510 / Clinical Chemistry
FDA source (opens on fda.gov)

NGJ is the FDA product code for Test, Nitrite, Urinary, Non-Quantitative, Over The Counter, a class I device type, regulated under 21 CFR 862.1510. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and one recall.

Classification record

Product code
NGJ
Device name
Test, Nitrite, Urinary, Non-Quantitative, Over The Counter
Regulation
21 CFR 862.1510
Device class
Class I
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
1
Ingested recalls
1

Clearances, product code NGJ

By decision year
1 clearance under product code NGJ with a decision year between 2012 and 2012, 2012 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NGJ by decision year
YearClearances
20121

Applicants with the most clearances

Product code NGJ
Applicants holding the most 510(k) clearances under product code NGJ
ApplicantClearances
Ind Diagnostic, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code