FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXTRACTABLE NUCLEAR ANTIGEN ASSAY
K Number: K840221
·
Decision May 22, 1984
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
179
Applicant Total
135
Review Days
124
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Basic Information
- Device Name
- EXTRACTABLE NUCLEAR ANTIGEN ASSAY
- K Number
- K840221
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Zeus Scientific, Inc.
- Date Received
- January 19, 1984
- Decision Date
- May 22, 1984
- Product Code
- LLL
- Advisory Committee
- Immunology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| LLL | Extractable Antinuclear Antibody, Antigen And Control | FDA class 2 | Immunology |
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