FDA product code DLG: Coating, Liquid, Glc
DLG is the FDA product code for coating, liquid, glc. It is a Class I device, regulated under 21 CFR 862.2250 and reviewed by the Clinical Toxicology panel. FDA has cleared 7 510(k) submissions under DLG, from 5 different applicants. The average 510(k) review took 104 days (median 70).
Classification
| Field | Value |
|---|---|
| Device name | Coating, Liquid, Glc |
| Device class | Class I |
| Regulation | 21 CFR 862.2250 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DLG clearance
Top DLG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Colony Laboratories, Inc. | 3 | 1989-09-28 |
| Lin-Zhi International, Inc. | 1 | 2006-04-06 |
| Instrumentation Laboratory CO | 1 | 1992-03-11 |
| Em Diagnostic Systems, Inc. | 1 | 1988-08-23 |
| E.I. Dupont DE Nemours & Co., Inc. | 1 | 1983-12-16 |
Most recent DLG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K050988 | Lin-Zhi International, Inc. | OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS | 2006-04-06 | 352 |
| K920419 | Instrumentation Laboratory CO | IL TEST DAT CAL/CONTROL SET D/E | 1992-03-11 | 40 |
| K894518 | Colony Laboratories, Inc. | FPR AMIKACIN CALIBRATOR KIT | 1989-09-28 | 70 |
| K894524 | Colony Laboratories, Inc. | FPR GENTAMICIN CALIBRATOR KIT | 1989-09-28 | 70 |
| K894528 | Colony Laboratories, Inc. | FPR PHENYTOIN CALIBRATOR KIT | 1989-09-25 | 67 |
Recalls for DLG devices
openFDA lists no recalls for product code DLG.
Frequently asked questions
What is FDA product code DLG?
DLG is the FDA product code for coating, liquid, glc. It is a Class I device, regulated under 21 CFR 862.2250 and reviewed by the Clinical Toxicology panel.
What device class is DLG?
Class I, regulation 21 CFR 862.2250. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DLG?
Across 7 cleared submissions the average was 104 days from receipt to decision (median 70).
Which companies have the most DLG clearances?
Colony Laboratories, Inc. (3); Lin-Zhi International, Inc. (1); Instrumentation Laboratory CO (1); Em Diagnostic Systems, Inc. (1); E.I. Dupont DE Nemours & Co., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DLG
- Run a recall and safety report across every DLG manufacturer
- Watch product code DLG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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