510(k) K895094— TANDEM-E LH IMMUNOENZYMETRIC ASSAY KIT
Substantially EquivalentHybritech, Inc.
Clearance details
- Applicant
- Hybritech, Inc.
- Product code
- Code CEP
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.