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

Alcohol Control Materials

21 CFR 862.3280 / Clinical Toxicology
FDA source (opens on fda.gov)

DKC is the FDA product code for Alcohol Control Materials, a class I device type, regulated under 21 CFR 862.3280. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and 5 recalls.

Classification record

Product code
DKC
Device name
Alcohol Control Materials
Regulation
21 CFR 862.3280
Device class
Class I
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
11
Ingested recalls
5

Clearances, product code DKC

By decision year
11 clearances under product code DKC with a decision year between 1980 and 2003, 1993 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code DKC by decision year
YearClearances
19801
19811
19831
19841
19912
19933
19941
20031

Applicants with the most clearances

Product code DKC
Applicants holding the most 510(k) clearances under product code DKC
ApplicantClearances
Cala Diagnostics2
Sigma Diagnostics, Inc.2
Syva Co.2
Beckman-Diagnostic Systems Group1
Columbia Diagnostics, Inc.1
Fisher Diagnostics1
Medical Analysis Systems, Inc.1
Sigma Chemical Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code