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

Urease, Photometric, Urea Nitrogen

21 CFR 862.1770 / Clinical Chemistry
FDA source (opens on fda.gov)

CDN is the FDA product code for Urease, Photometric, Urea Nitrogen, a class II device type, regulated under 21 CFR 862.1770. As of , FDA records hold 16 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
CDN
Device name
Urease, Photometric, Urea Nitrogen
Regulation
21 CFR 862.1770
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
16
Ingested recalls
2

Clearances, product code CDN

By decision year
16 clearances under product code CDN with a decision year between 1977 and 2019, 2013 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code CDN by decision year
YearClearances
19771
19781
19791
19801
19821
19911
19921
19941
19961
19971
20001
20111
20121
20132
20191

Applicants with the most clearances

Product code CDN
Applicants holding the most 510(k) clearances under product code CDN
ApplicantClearances
Alfa Wassermann Diagnostic Technologies, Inc.2
Ortho-Clinical Diagnostics, Inc.2
Alfa Wassermann Diagnostics Technologies, LLC1
Boehringer Mannheim Corp.1
Cholestech Corp.1
Coulter Electronics, Inc.1
Em Diagnostic Systems, Inc.1
Canon Medical Diagnostics USA, Inc.1
Instrumentation Laboratory Co.1
Johnson & Johnson Clinical Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code