510(k) K031834— XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY
Substantially EquivalentRemel, Inc.
Clearance details
- Applicant
- Remel, Inc.
- Product code
- Code MHI
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lenexa, KS, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.