OPUS MYOGLOBIN TEST SYSTEM— 510(k) K915850
Substantially EquivalentPb Diagnostic Systems, Inc.
FDA 510(k) clearance K915850 for OPUS MYOGLOBIN TEST SYSTEM, Substantially Equivalent on 1992-03-17. Applicant: Pb Diagnostic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Pb Diagnostic Systems, Inc.
- Product code
- Code DDR
- Device class
- Class 2
- Regulation
- 21 CFR 866.5680
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westwood, MA, US
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More clearances from Pb Diagnostic Systems, Inc.
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