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

Berthelot Indophenol, Urea Nitrogen

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

CDL is the FDA product code for Berthelot Indophenol, 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 one recall.

Classification record

Product code
CDL
Device name
Berthelot Indophenol, 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
1

Clearances, product code CDL

By decision year
16 clearances under product code CDL with a decision year between 1976 and 1990, 1986 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code CDL by decision year
YearClearances
19761
19782
19791
19802
19811
19821
19831
19863
19872
19891
19901

Applicants with the most clearances

Product code CDL
Applicants holding the most 510(k) clearances under product code CDL
ApplicantClearances
Volu Sol Medical Industries2
Advanced Biomedical Methods, Inc.1
Analytical & Research Chemicals, Inc.1
Bio-Analytics Laboratories, Inc.1
Biochemical Trade, Inc.1
Data Medical Associates, Inc.1
J. D. Assoc.1
Reagents Applications, Inc.1
Sclavo, Inc.1
Stanbio Laboratory1

Companies listing this code with FDA

Companies whose registered establishments list this code