FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
QUANTA LITE RUBEOLA (MEASLES) IGG
K Number: K971620
·
Decision Jul 22, 1997
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
10
Applicant Total
138
Review Days
82
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Basic Information
- Device Name
- QUANTA LITE RUBEOLA (MEASLES) IGG
- K Number
- K971620
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3520
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Inova Diagnostics, Inc.
- Date Received
- May 1, 1997
- Decision Date
- July 22, 1997
- Product Code
- LJB
- 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 |
|---|---|---|---|
| LJB | Enzyme Linked Immunoabsorbent Assay, Rubeola Igg | FDA class 1 | Microbiology |
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