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

Electrode, Ion Specific, Urea Nitrogen

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

CDS is the FDA product code for Electrode, Ion Specific, Urea Nitrogen, a class II device type, regulated under 21 CFR 862.1770. As of , FDA records hold 15 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
CDS
Device name
Electrode, Ion Specific, 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
15
Ingested recalls
1

Clearances, product code CDS

By decision year
15 clearances under product code CDS with a decision year between 1976 and 2018, 1980 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code CDS by decision year
YearClearances
19761
19772
19791
19803
19812
19862
19931
20042
20181

Applicants with the most clearances

Product code CDS
Applicants holding the most 510(k) clearances under product code CDS
ApplicantClearances
Beckman Instruments, Inc.1
Boehringer Mannheim Corp.1
Chem-Elec, Inc.1
DIAMOND DIAGNOSTICS Inc1
Epocal Inc1
Fermco Biochemics, Inc.1
Fisher Scientific Company L.L.C.1
Genchem, Inc.1
Hi Chem, Inc.1
Hichem Diagnostics1

Companies listing this code with FDA

Companies whose registered establishments list this code