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

Calibrators, Ethyl Alcohol

21 CFR 862.3200 / Clinical Toxicology
FDA source (opens on fda.gov)

DNN is the FDA product code for Calibrators, Ethyl Alcohol, a class II device type, regulated under 21 CFR 862.3200. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
DNN
Device name
Calibrators, Ethyl Alcohol
Regulation
21 CFR 862.3200
Device class
Class II
Review panel
Clinical Toxicology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
7
Ingested recalls
2

Clearances, product code DNN

By decision year
7 clearances under product code DNN with a decision year between 1980 and 1999, 1980 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DNN by decision year
YearClearances
19801
19811
19851
19881
19921
19971
19991

Applicants with the most clearances

Product code DNN
Applicants holding the most 510(k) clearances under product code DNN
ApplicantClearances
EMD Millipore Corporation2
Syva Co.2
Diagnostic Reagents, Inc.1
Diagnostic Systems1
Verichem Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code