FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENT
K Number: K033056
·
Decision Jan 30, 2004
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
14
Applicant Total
26
Review Days
123
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Basic Information
- Device Name
- BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENT
- K Number
- K033056
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1770
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Diamond Diagnostics, Inc.
- Date Received
- September 29, 2003
- Decision Date
- January 30, 2004
- Product Code
- CDS
- 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 |
|---|---|---|---|
| CDS | Electrode, Ion Specific, Urea Nitrogen | FDA class 2 | Clinical Chemistry |
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