510(k) K992148— HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KIT
Substantially EquivalentMorax
Clearance details
- Applicant
- Morax
- Product code
- Code CGS
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chelsea, MI, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.