FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OPUS RUBELLA TEST SYSTEM
K Number: K915870
·
Decision Mar 23, 1992
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
93
Applicant Total
4
Review Days
83
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Basic Information
- Device Name
- OPUS RUBELLA TEST SYSTEM
- K Number
- K915870
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3510
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pb Diagnostics, Inc.
- Date Received
- December 31, 1991
- Decision Date
- March 23, 1992
- Product Code
- LFX
- Advisory Committee
- Microbiology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | FDA class 2 | Microbiology |
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