FPR Theophylline Calibrator Kit
FDA 510(k) K894530 · Colony Laboratories, Inc.
510(k) numberK894530
Submission
- Device name
- FPR Theophylline Calibrator Kit
- Applicant
- Colony Laboratories, Inc.
Washington, DC, US - Received
- July 20, 1989
- Decision date
- September 18, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DLJ – Calibrators, Drug Specific
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3200
- Specialty
- Clinical Toxicology
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More from Labone, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K894524 | FPR Gentamicin Calibrator KitDLG · Traditional | 09/28/1989SE |
| K894523 | FPR Gentamicin KitLCQ · Traditional | 09/28/1989SE |
| K894518 | FPR Amikacin Calibrator KitDLG · 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 |
| K894529 | FPR Theophylline KitLGS · Traditional | 09/15/1989SE |
| K894532 | FPR Tobramycin Calibrator KitDLJ · Traditional | 09/01/1989SE |
Questions and answers
When was FPR Theophylline Calibrator Kit cleared by the FDA?
FPR Theophylline Calibrator Kit (K894530) received a 510(k) decision of Substantially Equivalent on September 18, 1989, 60 days after the submission was received.
What is the product code of K894530?
The FDA product code is DLJ – Calibrators, Drug Specific, a Class II (moderate risk) device regulated under 21 CFR 862.3200.