Helix Opco, LLC FDA Record
Helix Opco, LLC has 0 FDA recalls, 0 inspections, 2 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Helix Opco, LLC" is on file.
- Latest 510(k)
- Dec 23, 2020
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 2 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 0 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K192073 | Helix Genetic Health Risk App for late-onset Alzheimers disease | Dec 23, 2020 |
| DEN190035 | Helix Laboratory Platform | Dec 23, 2020 |
Helix Opco, LLC and the FDA: common questions
Has Helix Opco, LLC received an FDA warning letter?
No FDA warning letter addressed to the name "Helix Opco, LLC" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Helix Opco, LLC received an FDA Form 483?
FDA has not published a Form 483 for "Helix Opco, LLC" in its reading room. FDA publishes some Form 483s, not all of them.
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