OPUS(R) SEROLOGY CONTROLS, MODIFICATION— 510(k) K934137
Substantially EquivalentPb Diagnostic Systems, Inc.
FDA 510(k) clearance K934137 for OPUS(R) SEROLOGY CONTROLS, MODIFICATION, Substantially Equivalent on 1994-03-07. Applicant: Pb Diagnostic Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Pb Diagnostic Systems, 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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