FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OPUS SEROLOGY CONTROLS
K Number: K925703
·
Decision Apr 8, 1993
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
6
Applicant Total
4
Review Days
147
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Basic Information
- Device Name
- OPUS SEROLOGY CONTROLS
- K Number
- K925703
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pb Diagnostics, Inc.
- Date Received
- November 12, 1992
- Decision Date
- April 8, 1993
- Product Code
- MJX
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| MJX | Kit, Serological, Positive Control | FDA class 1 | Clinical Chemistry |
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