CARESTART HCG ONE-STEP PREGNANCY TEST— 510(k) K031052
Substantially EquivalentAccess Bio Incorporate
FDA 510(k) clearance K031052 for CARESTART HCG ONE-STEP PREGNANCY TEST, Substantially Equivalent on 2003-06-13. Applicant: Access Bio Incorporate.
Clearance details
- Applicant
- Access Bio Incorporate
- Product code
- Code DHA
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- North Brunswick, NJ, US
Adverse events under product code DHA
product code DHA- Malfunction
- 1,242
- Total
- 1,242
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.