ACCESS TOTAL BHCG (5TH IS)— 510(k) K130020
Substantially EquivalentBeckman Coulter, Inc.
FDA 510(k) clearance K130020 for ACCESS TOTAL BHCG (5TH IS), Substantially Equivalent on 2013-10-01. Applicant: Beckman Coulter, Inc.. Device class: 2.
Clearance details
- Applicant
- Beckman Coulter, Inc.
- 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
- Chaska, MN, US
Recent devices under product code DHA
view all- K233581 — VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack
- K223690 — iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)
- K230937 — Alinity i Total ß-hCG Reagent Kit, GLP systems Track
- K230790 — Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series
- K221990 — Access Total ßhCG (5th IS)
More clearances from Beckman Coulter, Inc.
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.