Coating, Liquid, Glc
FDA product code DLG · Class I (low risk) · 21 CFR 862.2250 · Clinical Chemistry
7510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K050988 | Opiate Oral Fluid Homogeneous Enzyme Immunoassay, Calibrators and ControlsDLG · Traditional | Lin-Zhi International, Inc. | 04/06/2006SE |
| K920419 | Il Test Dat Cal/Control Set D/EDLG · Traditional | Instrumentation Laboratory CO | 03/11/1992SE |
| K894524 | FPR Gentamicin Calibrator KitDLG · Traditional | Colony Laboratories, Inc. | 09/28/1989SE |
| K894518 | FPR Amikacin Calibrator KitDLG · Traditional | Colony Laboratories, Inc. | 09/28/1989SE |
| K894528 | FPR Phenytoin Calibrator KitDLG · Traditional | Colony Laboratories, Inc. | 09/25/1989SE |
| K882766 | Emds Acetaminophen Calibrator No. 67636/95DLG · Traditional | Em Diagnostic Systems, Inc. | 08/23/1988SE |
| K833385 | N-Acetylprocainamide CalibratorDLG · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 12/16/1983SE |