510(k) K913938— OPUS(R) LH TEST SYSTEM
Substantially EquivalentPb Diagnostic Systems, Inc.
Clearance details
- Applicant
- Pb Diagnostic Systems, Inc.
- Product code
- Code CEP
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westwood, MA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.