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

Coating, Liquid, Glc

21 CFR 862.2250 / Clinical Chemistry
FDA source (opens on fda.gov)

DLG is the FDA product code for Coating, Liquid, Glc, a class I device type, regulated under 21 CFR 862.2250. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DLG
Device name
Coating, Liquid, Glc
Regulation
21 CFR 862.2250
Device class
Class I
Review panel
Clinical Chemistry
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
0

Clearances, product code DLG

By decision year
7 clearances under product code DLG with a decision year between 1983 and 2006, 1989 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code DLG by decision year
YearClearances
19831
19881
19893
19921
20061

Applicants with the most clearances

Product code DLG
Applicants holding the most 510(k) clearances under product code DLG
ApplicantClearances
Colony Laboratories, Inc.3
E.I. Dupont de Nemours & Co., Inc.1
Em Diagnostic Systems, Inc.1
Instrumentation Laboratory Co.1
Lin-Zhi International Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code