Data / Medical devices / France / Immunotech SAS, a Beckman Coulter company
Immunotech SAS, a Beckman Coulter company: FDA-registered device maker in MARSEILLE, CEDEX 9 Bouches-du-Rhone, France, 14 510(k) clearances and 1 PMA approval
Immunotech SAS, a Beckman Coulter company is registered with the FDA (registration 8023018) in MARSEILLE, CEDEX 9 Bouches-du-Rhone, France. It lists 19 device types. The FDA files 14 510(k) clearances and 1 PMA approval under its listings, the newest dated March 13, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8023018
- FEI number
- 3002807272
- Address
- 130 Avenue De Lattre De Tassigny BP 177, MARSEILLE, CEDEX 9 Bouches-du-Rhone, France, 13276
- Owner or operator
- BECKMAN COULTER, INC. (2050012)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- December 14, 1977
- Registered through
- 2026
- Brand names listed
- 7-AAD Viability Dye 150t, ACCESS anti-HAV IgM 2x100 DET US (D25834), ACCESS anti-HAV IgM Calibrator 1x2 mL US (D25835), ACCESS anti-HAV IgM QC 2x4 mL (3 ea) US (D25836), ACCESS anti-HBc IgM, Access anti-HBc IgM Calibrator, Access anti-HBc IgM QC, ANTI-IL2-FITC, 1ML ASR, AQUIOS CL Flow Cytometer, AQUIOS Lysing Reagent Kit and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| March 13, 2026 | K254059 | Access anti-HBc IgM | SEI | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| February 19, 2026 | K253687 | Access anti-HBc Total | SEI | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| January 27, 2026 | K251995 | Access anti-HAV IgM | LOL | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| September 9, 2025 | K243846 | Access anti-HAV | LOL | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| August 9, 2024 | K240469 | Access TPO Antibody | JZO | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| March 1, 2024 | K232791 | Access Intact PTH | CEW | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| February 3, 2023 | K223679 | Access AMH | PQO | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| January 19, 2023 | K223503 | Access 25(OH) Vitamin D Total | MRG | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| November 13, 2017 | K170524 | Access AMH | PQO | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| December 22, 2014 | K142373 | Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access 25(OH) Vitamin D Total Calibrators for Use on the Access 2 Immuno. Syst | MRG | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| December 19, 2014 | K142362 | Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25(OH) Vitamin D Total Calibrators for Use on the UniCel Dxl Immuno. | MRG | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| September 15, 2006 | K061190 | ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953 | CEW | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| July 6, 2006 | K061382 | ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227 | JZO | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| October 5, 2004 | K042651 | FREE T3 CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS | JIT | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| October 17, 2025 | P230015 | Access HBsAg, Access HBsAg Confirmatory, Access HBsAg Calibrator, Access HBsAg QC | LOM | 0 | October 17, 2025 | accessdata.fda.gov |
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Updated March 13, 2026. 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.