510(k) K872727— LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT, MAG. PHASE
Substantially EquivalentSerono Diagnostics, Inc.
Clearance details
- Applicant
- Serono Diagnostics, Inc.
- Product code
- Code CEP
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Norwell, MA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.