HUMAN CHORIONIC GONAD TEST SYS FOR EARLY PREGNANCY— 510(k) K853006
Substantially EquivalentModern Diagnostics, Inc.
FDA 510(k) clearance K853006 for HUMAN CHORIONIC GONAD TEST SYS FOR EARLY PREGNANCY, Substantially Equivalent on 1985-09-04. Applicant: Modern Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Modern Diagnostics, Inc.
- Product code
- Code JHI
- Device class
- Class 2
- Regulation
- 21 CFR 862.1155
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sacramento, CA, US
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More clearances from Modern Diagnostics, Inc.
view allAdverse 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.