FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMMULITE CEA
K Number: K970877
·
Decision Sep 22, 1997
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
27
Applicant Total
321
Review Days
196
Basic Information
- Device Name
- IMMULITE CEA
- K Number
- K970877
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.6010
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DIAGNOSTIC PRODUCTS CORP.
- Date Received
- March 10, 1997
- Decision Date
- September 22, 1997
- Product Code
- DHX
- 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 |
|---|---|---|---|
| DHX | System, Test, Carcinoembryonic Antigen | FDA class 2 | Immunology |
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