HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE— 510(k) K041728
Substantially EquivalentImmunostics Inc.,
FDA 510(k) clearance K041728 for HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE, Substantially Equivalent on 2004-08-11. Applicant: Immunostics Inc.,. Device class: 2.
Clearance details
- Applicant
- Immunostics 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
- Ocean, NJ, US
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More clearances from Immunostics 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.