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

Nad-Nadh, Specific Reagent For Alcohol Enzyme Method

21 CFR 862.3040 / Clinical Toxicology
FDA source (opens on fda.gov)

DML is the FDA product code for Nad-Nadh, Specific Reagent For Alcohol Enzyme Method, a class II device type, regulated under 21 CFR 862.3040. As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
DML
Device name
Nad-Nadh, Specific Reagent For Alcohol Enzyme Method
Regulation
21 CFR 862.3040
Device class
Class II
Review panel
Clinical Toxicology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
13
Ingested recalls
1

Clearances, product code DML

By decision year
13 clearances under product code DML with a decision year between 1984 and 2001, 1984 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code DML by decision year
YearClearances
19843
19861
19871
19881
19911
19931
19952
19961
20001
20011

Applicants with the most clearances

Product code DML
Applicants holding the most 510(k) clearances under product code DML
ApplicantClearances
Abbott Medical2
Syva Co.2
American Dade1
American Monitor Corp.1
Ansys, Inc.1
Boehringer Mannheim Corp.1
Em Diagnostic Systems, Inc.1
Reagents Applications, Inc.1
Sigma Diagnostics, Inc.1
Syva Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code