FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMMUSTRIP HAMA IGG
K Number: K972873
·
Decision Mar 17, 1998
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
27
Applicant Total
4
Review Days
225
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Basic Information
- Device Name
- IMMUSTRIP HAMA IGG
- K Number
- K972873
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5240
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Immunomedics, Inc.
- Date Received
- August 4, 1997
- Decision Date
- March 17, 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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