hema-screen SPECIFIC Gold— 510(k) K171484
Substantially EquivalentImmunostics Inc.,
FDA 510(k) clearance K171484 for hema-screen SPECIFIC Gold, Substantially Equivalent on 2017-06-14. Applicant: Immunostics Inc.,.
Clearance details
- Applicant
- Immunostics Inc.,
- Product code
- Code KHE
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Ocean, NJ, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.