CA-1000 AUTOMATED COAGULATION ANALYZER— 510(k) K931149
Substantially EquivalentToa Medical Electronics USA, Inc.
FDA 510(k) clearance K931149 for CA-1000 AUTOMATED COAGULATION ANALYZER, Substantially Equivalent on 1993-11-03. Applicant: Toa Medical Electronics USA, Inc..
Clearance details
- Applicant
- Toa Medical Electronics USA, Inc.
- Product code
- Code JPA
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Los Alamitos, CA, US
Adverse events under product code JPA
product code JPA- Death
- 6
- Total
- 6
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.