Data / Medical devices / Norway / Abbott Diagnostics Technologies AS
Abbott Diagnostics Technologies AS: FDA-registered device maker in Oslo, Norway, 7 510(k) clearances
Abbott Diagnostics Technologies AS is registered with the FDA (registration 9613069) in Oslo, Norway. It lists 11 device types. The FDA files 7 510(k) clearances under its listings, the newest dated September 27, 2023. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9613069
- FEI number
- 3003045237
- Address
- Kjelsaasveien 161, Oslo, Norway, NO-0884
- Owner or operator
- ABBOTT LABORATORIES (1415939)
- Roles
- Manufacturer
- First device listed
- November 21, 2013
- Registered through
- 2027
- Brand names listed
- Afinion 2, Afinion ACR, Afinion ACR Control, Afinion HbA1c, Afinion HbA1c Calibration Verification, Afinion HbA1c Control, Afinion HbA1c Dx, Afinion 2 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Assay, Glycosylated Hemoglobin | LCP | 2 | Manufacturer | accessdata.fda.gov |
| C-Reactive Protein, Antigen, Antiserum, And Control | DCK | 2 | Manufacturer | accessdata.fda.gov |
| Colorimetric Method, Triglycerides | JGY | 1 | Manufacturer | accessdata.fda.gov |
| Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica | JQT | 1 | Manufacturer | accessdata.fda.gov |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | 1 | Manufacturer | accessdata.fda.gov |
| Enzymatic Method, Creatinine | JFY | 2 | Manufacturer | accessdata.fda.gov |
| Hemoglobin A1c Test System | PDJ | 2 | Manufacturer | accessdata.fda.gov |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | 1 | Manufacturer | accessdata.fda.gov |
| Ldl & Vldl Precipitation, Hdl | LBR | 1 | Manufacturer | accessdata.fda.gov |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | 1 | Manufacturer | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 27, 2023 | K214117 | Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer | LCP | Substantially Equivalent | Abbott Diagnostics Technologies AS | accessdata.fda.gov |
| November 29, 2018 | K182988 | Afinion HbA1c Dx on Afinion 2 | PDJ | Substantially Equivalent | Alere Technologies AS | accessdata.fda.gov |
| May 7, 2018 | K180296 | Afinion HbA1c Dx | PDJ | Substantially Equivalent | Alere Technologies AS | accessdata.fda.gov |
| November 21, 2017 | K171650 | Alere Afinion HbA1c and ACR on Afinion 2 analyzer | LCP | Substantially Equivalent | Abbott Rapid Diagnostics | accessdata.fda.gov |
| September 25, 2015 | K151809 | Alere Afinion HbA1c, Alere Afinion AS100 Analyzer | LCP | Substantially Equivalent | Alere Technologies AS | accessdata.fda.gov |
| March 21, 2014 | K132031 | AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL | CHH | Substantially Equivalent | Axis-Shield Poc AS | accessdata.fda.gov |
| February 15, 2011 | K110056 | AFINION ANALYZER | LCP | Substantially Equivalent | Axis-Shield Poc AS | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 17, 2024 | 94910 | Class II | Ongoing | Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived. | Five Afinion 2 (AF2) Analyzer were incorrectly market configured as Moderate Complexity and distributed to customers. Use of moderately complex assays by waived laboratories could result in erroneous results. | accessdata.fda.gov |
| March 23, 2020 | 85313 | Class II | Ongoing | Power supply provided with Afinion 2, Catalog numbers 1116553, 1116554, 1116556, 1116557, 1116597, 1116598, 1116663, 1116679, 1116680, 1116681, 1116682, 1116684, 1116770, 1116771, 1116772, 1116777, 1116778, 1116970, 1116 | The analyzer system may have an electrostatic discharge and sparking of the power supply provided with the analyzers resulting in the power supply becoming non-functional. | accessdata.fda.gov |
Compare with other makers
- All makers of Hemoglobin A1c Test System
- All makers of Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
- All makers of Assay, Glycosylated Hemoglobin
- All makers of Enzymatic Method, Creatinine
- All makers of Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
- All makers of C-Reactive Protein, Antigen, Antiserum, And Control
Updated August 27, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.