FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIMENSION CTNI FLEX REAGENT CARTRIDGE
K Number: K010313
·
Decision Apr 20, 2001
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
91
Applicant Total
343
Review Days
77
Basic Information
- Device Name
- DIMENSION CTNI FLEX REAGENT CARTRIDGE
- K Number
- K010313
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1215
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DADE BEHRING, INC.
- Date Received
- February 2, 2001
- Decision Date
- April 20, 2001
- Product Code
- MMI
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| MMI | Immunoassay Method, Troponin Subunit | FDA class 2 | Clinical Chemistry |
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