FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RUBELLACOL
K Number: K031490
·
Decision Jul 16, 2003
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
12
Applicant Total
14
Review Days
65
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Basic Information
- Device Name
- RUBELLACOL
- K Number
- K031490
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3510
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Immunostics Inc.,
- Date Received
- May 12, 2003
- Decision Date
- July 16, 2003
- Product Code
- LQN
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| LQN | Latex Agglutination Assay, Rubella | FDA class 2 | Microbiology |
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