RH-HR NEGATIVE CONTROL REAGENT— 510(k) K800239
Substantially EquivalentGotham Biologics, Inc.
FDA 510(k) clearance K800239 for RH-HR NEGATIVE CONTROL REAGENT, Substantially Equivalent on 1980-02-21. Applicant: Gotham Biologics, Inc..
Clearance details
- Applicant
- Gotham Biologics, Inc.
- Product code
- Code KSF
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.