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

Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method

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

DIC is the FDA product code for Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method, a class II device type, regulated under 21 CFR 862.3040. As of , FDA records hold 33 510(k) clearances under this code, the most recent dated , and 6 recalls.

Classification record

Product code
DIC
Device name
Alcohol Dehydrogenase, Specific Reagent For Ethanol 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
33
Ingested recalls
6

Clearances, product code DIC

By decision year
33 clearances under product code DIC with a decision year between 1977 and 2025, 1990 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code DIC by decision year
YearClearances
19771
19841
19851
19871
19892
19904
19911
19931
19941
19961
19972
19981
20002
20011
20021
20031
20061
20072
20102
20112
20121
20131
20181
20251

Applicants with the most clearances

Product code DIC
Applicants holding the most 510(k) clearances under product code DIC
ApplicantClearances
Sekisui Diagnostics P.E.I. Inc.4
Abbott Medical3
Siemens Healthcare Diagnostics Inc.3
Chematics, Inc.2
E.I. Dupont de Nemours & Co., Inc.2
Enzymatics C/O Burditt,Bowles,Radzius & Ruberry2
Acon Laboratories, Inc.1
Baxter Diagnostics, Inc.1
Bayer Diagnostics Corp.1
Behring Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 22 companies shown, in name order