510(k) K951630— AURAFLEX PROGESTERONE 150TEST PACK
Substantially EquivalentOrganon Teknika Corp.
Clearance details
- Applicant
- Organon Teknika Corp.
- Product code
- Code JLS
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Durham, NC, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.