FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES
K Number: K973203
·
Decision Sep 30, 1998
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
27
Applicant Total
3
Review Days
400
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Basic Information
- Device Name
- THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES
- K Number
- K973203
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5240
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sangstat Medical Corp.
- Date Received
- August 26, 1997
- Decision Date
- September 30, 1998
- Product Code
- DAK
- 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 |
|---|---|---|---|
| DAK | Complement C1q, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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