HEMAFLUOR REAGENT KIT— 510(k) K860309
Substantially EquivalentHelena Laboratories
FDA 510(k) clearance K860309 for HEMAFLUOR REAGENT KIT, Substantially Equivalent on 1986-07-14. Applicant: Helena Laboratories.
Clearance details
- Applicant
- Helena Laboratories
- Product code
- Code KHO
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beaumont, TX, US
Adverse events under product code KHO
product code KHO- Malfunction
- 1,339
- Total
- 1,339
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.