FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RABBIT COMPLEMENT
K Number: K770866
·
Decision Jun 3, 1977
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
3
Applicant Total
1
Review Days
23
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Basic Information
- Device Name
- RABBIT COMPLEMENT
- K Number
- K770866
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.4100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Cedarlake Labs , Ltd.
- Date Received
- May 11, 1977
- Decision Date
- June 3, 1977
- Product Code
- DHL
- 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 |
|---|---|---|---|
| DHL | Protein, Complement, Antigen, Antiserum, Control | FDA class 1 | Immunology |
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