DLG
7 FDA 510(k) clearances · Product code
70 daysmedian time to decision
352 days90th percentile
7clearances measured
FDA profile
- Official device name
- Coating, Liquid, Glc
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2250
- Medical specialty
- Clinical Chemistry
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS (K050988) | Lin-Zhi International, Inc. | 2006-04-06 |
| IL TEST DAT CAL/CONTROL SET D/E (K920419) | Instrumentation Laboratory CO | 1992-03-11 |
| FPR GENTAMICIN CALIBRATOR KIT (K894524) | Colony Laboratories, Inc. | 1989-09-28 |
| FPR AMIKACIN CALIBRATOR KIT (K894518) | Colony Laboratories, Inc. | 1989-09-28 |
| FPR PHENYTOIN CALIBRATOR KIT (K894528) | Colony Laboratories, Inc. | 1989-09-25 |
| EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95 (K882766) | Em Diagnostic Systems, Inc. | 1988-08-23 |
| N-ACETYLPROCAINAMIDE CALIBRATOR (K833385) | E.I. Dupont DE Nemours & Co., Inc. | 1983-12-16 |
Track DLG automatically
Every clearance here is in the API, with alerts when new ones post.