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

Diacetyl-Monoxime, Urea Nitrogen

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

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

Classification record

Product code
CDW
Device name
Diacetyl-Monoxime, 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
21
Ingested recalls
2

Clearances, product code CDW

By decision year
21 clearances under product code CDW with a decision year between 1976 and 1988, 1977 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code CDW by decision year
YearClearances
19761
19774
19783
19802
19811
19822
19842
19851
19863
19871
19881

Applicants with the most clearances

Product code CDW
Applicants holding the most 510(k) clearances under product code CDW
ApplicantClearances
American Research Products Co.2
Analytical & Research Chemicals, Inc.1
Anco Medical Reagents & Assoc.1
Boehringer Mannheim Corp.1
Catachem, Inc.1
Diagnostic Solutions, Inc.1
Dilab, Inc.1
Fisher Scientific Company L.L.C.1
Gamma Enterprises, Inc.1
Harleco1

Companies listing this code with FDA

Companies whose registered establishments list this code

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