FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FPR DIGOXIN CALIBRATOR KIT
K Number: K894522
·
Decision Sep 25, 1989
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
122
Applicant Total
16
Review Days
67
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Basic Information
- Device Name
- FPR DIGOXIN CALIBRATOR KIT
- K Number
- K894522
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3200
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Colony Laboratories, Inc.
- Date Received
- July 20, 1989
- Decision Date
- September 25, 1989
- Product Code
- DLJ
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DLJ | Calibrators, Drug Specific | FDA class 2 | Clinical Toxicology |
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Other Clearances by Colony Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K894524 | FPR GENTAMICIN CALIBRATOR KIT | Sep 28, 1989 | Substantially Equivalent |
| K894517 | FPR AMIKACIN KIT | Sep 28, 1989 | Substantially Equivalent |
| K894523 | FPR GENTAMICIN KIT | Sep 28, 1989 | Substantially Equivalent |
| K894518 | FPR AMIKACIN CALIBRATOR KIT | Sep 28, 1989 | Substantially Equivalent |
| K894521 | FPR DIGOXIN KIT | Sep 25, 1989 | Substantially Equivalent |
| K894527 | FPR PHENYTOIN KIT | Sep 25, 1989 | Substantially Equivalent |
| K894528 | FPR PHENYTOIN CALIBRATOR KIT | Sep 25, 1989 | Substantially Equivalent |
| K894530 | FPR THEOPHYLLINE CALIBRATOR KIT | Sep 18, 1989 | Substantially Equivalent |
| K894529 | FPR THEOPHYLLINE KIT | Sep 15, 1989 | Substantially Equivalent |
| K894532 | FPR TOBRAMYCIN CALIBRATOR KIT | Sep 1, 1989 | Substantially Equivalent |