FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
3M ANTI-DSDNA FAST TEST
K Number: K913653
·
Decision Nov 7, 1991
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
28
Applicant Total
4
Review Days
83
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Basic Information
- Device Name
- 3M ANTI-DSDNA FAST TEST
- K Number
- K913653
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- 3M Diagnostic Systems, Inc.
- Date Received
- August 16, 1991
- Decision Date
- November 7, 1991
- Product Code
- LRM
- 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 |
|---|---|---|---|
| LRM | Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | FDA class 2 | Immunology |
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