FPR Amikacin Calibrator Kit
FDA 510(k) K894518 · Colony Laboratories, Inc.
510(k) numberK894518
Submission
- Device name
- FPR Amikacin Calibrator Kit
- Applicant
- Colony Laboratories, Inc.
Washington, DC, US - Received
- July 20, 1989
- Decision date
- September 28, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DLG – Coating, Liquid, Glc
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2250
- Specialty
- Clinical Chemistry
Other 510(k)s with product code DLG
| 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 |
| 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 |
More from E.I. Dupont DE Nemours & Co., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K894524 | FPR Gentamicin Calibrator KitDLG · Traditional | 09/28/1989SE |
| K894523 | FPR Gentamicin KitLCQ · Traditional | 09/28/1989SE |
| K894517 | FPR Amikacin KitKLQ · Traditional | 09/28/1989SE |
| K894528 | FPR Phenytoin Calibrator KitDLG · Traditional | 09/25/1989SE |
| K894527 | FPR Phenytoin KitDLP · Traditional | 09/25/1989SE |
| K894522 | FPR Digoxin Calibrator KitDLJ · Traditional | 09/25/1989SE |
| K894521 | FPR Digoxin KitKXT · Traditional | 09/25/1989SE |
| K894530 | FPR Theophylline Calibrator KitDLJ · Traditional | 09/18/1989SE |
| K894529 | FPR Theophylline KitLGS · Traditional | 09/15/1989SE |
| K894532 | FPR Tobramycin Calibrator KitDLJ · Traditional | 09/01/1989SE |
Questions and answers
When was FPR Amikacin Calibrator Kit cleared by the FDA?
FPR Amikacin Calibrator Kit (K894518) received a 510(k) decision of Substantially Equivalent on September 28, 1989, 70 days after the submission was received.
What is the product code of K894518?
The FDA product code is DLG – Coating, Liquid, Glc, a Class I (low risk) device regulated under 21 CFR 862.2250.