Alinity i Total ß-hCG Reagent Kit, GLP systems Track— 510(k) K230937
Substantially EquivalentAbbott Laboratories
FDA 510(k) clearance K230937 for Alinity i Total ß-hCG Reagent Kit, GLP systems Track, Substantially Equivalent on 2023-06-05. Applicant: Abbott Laboratories. Device class: 2.
Clearance details
- Applicant
- Abbott Laboratories
- Product code
- Code DHA
- Device class
- Class 2
- Regulation
- 21 CFR 862.1155
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Iriving, TX, US
Recent devices under product code DHA
view all- K233581 — VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack
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- K221990 — Access Total ßhCG (5th IS)
- K212221 — Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer
More clearances from Abbott Laboratories
view allAdverse events under product code DHA
product code DHA- Malfunction
- 1,242
- Total
- 1,242
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.