FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIMENSION C4 FLEX REAGENT CARTRIDGE
K Number: K994293
·
Decision Mar 1, 2000
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
33
Applicant Total
343
Review Days
71
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Basic Information
- Device Name
- DIMENSION C4 FLEX REAGENT CARTRIDGE
- K Number
- K994293
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5240
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dade Behring, Inc.
- Date Received
- December 21, 1999
- Decision Date
- March 1, 2000
- Product Code
- DBI
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| DBI | Complement C4, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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