FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LOW-TOX-H RABBIT COMPLEMENT
K Number: K790380
·
Decision Mar 21, 1979
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
5
Applicant Total
1
Review Days
22
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Basic Information
- Device Name
- LOW-TOX-H RABBIT COMPLEMENT
- K Number
- K790380
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.4100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Cederlane Labs , Ltd.
- Date Received
- February 27, 1979
- Decision Date
- March 21, 1979
- Product Code
- KTQ
- Advisory Committee
- Immunology
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| KTQ | Reagent, Complement | FDA class 1 | Immunology |
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