IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4)— 510(k) K955380
Substantially EquivalentInternational Biophysics Corp.
FDA 510(k) clearance K955380 for IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4), Substantially Equivalent on 1996-05-14. Applicant: International Biophysics Corp..
Clearance details
- Applicant
- International Biophysics Corp.
- Product code
- Code DRY
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Austin, TX, US
Adverse events under product code DRY
product code DRY- Death
- 5
- Total
- 5
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.