FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108
K Number: K052015
·
Decision Sep 12, 2005
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
122
Applicant Total
343
Review Days
48
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Basic Information
- Device Name
- DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108
- K Number
- K052015
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3200
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dade Behring, Inc.
- Date Received
- July 26, 2005
- Decision Date
- September 12, 2005
- 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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| K072965 | DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON | Dec 21, 2007 | Substantially Equivalent |