Rejoyn— 510(k) K231209
Substantially EquivalentOtsuka America Pharmaceutical, Inc.
FDA 510(k) clearance K231209 for Rejoyn, Substantially Equivalent on 2024-03-30. Applicant: Otsuka America Pharmaceutical, Inc..
Clearance details
- Applicant
- Otsuka America Pharmaceutical, Inc.
- Product code
- Code SAP
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rockville, MD, US
Adverse events under product code SAP
product code SAP- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.