510(k) K981391— PAR-ONE
Substantially EquivalentRemel, Inc.
Clearance details
- Applicant
- Remel, Inc.
- Product code
- Code LIO
- 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.