510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
DMTClass II

Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet

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

DMT is the FDA product code for Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet, a class II device type, regulated under 21 CFR 862.3040. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
DMT
Device name
Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet
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
8
Ingested recalls
1

Clearances, product code DMT

By decision year
8 clearances under product code DMT with a decision year between 1980 and 2000, 1980 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DMT by decision year
YearClearances
19801
19811
19841
19871
19931
19941
19971
20001

Applicants with the most clearances

Product code DMT
Applicants holding the most 510(k) clearances under product code DMT
ApplicantClearances
Syva Co.2
Siemens Healthcare Diagnostics Inc.1
Beckman Instruments, Inc.1
Diagnostic Chemicals, Ltd. (USA)1
Diagnostic Reagents, Inc.1
Eastman Kodak Company1
Em Diagnostic Systems, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code