OPUS SEROLOGY CONTROLS— 510(k) K925703
Substantially EquivalentPb Diagnostics, Inc.
FDA 510(k) clearance K925703 for OPUS SEROLOGY CONTROLS, Substantially Equivalent on 1993-04-08. Applicant: Pb Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Pb Diagnostics, Inc.
- Product code
- Code MJX
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westwood, MA, US
Recent devices under product code MJX
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