FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ABBOTT ARCHITECT CEA
K Number: K990774
·
Decision May 11, 1999
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
27
Applicant Total
883
Review Days
63
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Basic Information
- Device Name
- ABBOTT ARCHITECT CEA
- K Number
- K990774
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.6010
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Laboratories
- Date Received
- March 9, 1999
- Decision Date
- May 11, 1999
- 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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