MINISTRIP/ SERUM AND URINE COMBO HCG TEST— 510(k) K974060
Substantially EquivalentInternational Newtech Development, Inc.
FDA 510(k) clearance K974060 for MINISTRIP/ SERUM AND URINE COMBO HCG TEST, Substantially Equivalent on 1998-04-09. Applicant: International Newtech Development, Inc..
Clearance details
- Applicant
- International Newtech Development, Inc.
- Product code
- Code JHI
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Delta, B.C., CA
Adverse events under product code JHI
product code JHI- Malfunction
- 1,055
- Total
- 1,055
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.