Data / Medical devices / France / Bio-Rad
Bio-Rad: FDA-registered device maker in STEENVOORDE Nord, France, 8 510(k) clearances
Bio-Rad is registered with the FDA (registration 8023060) in STEENVOORDE Nord, France. It lists 17 device types. The FDA files 8 510(k) clearances under its listings, the newest dated December 28, 2017. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 8023060
- FEI number
- 3003992026
- Address
- Route De Cassel, STEENVOORDE Nord, France, 59114
- Owner or operator
- BIO-RAD (8023061)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- August 14, 1989
- Registered through
- 2027
- Brand names listed
- ACCESS CEA, ACCESS RUBELLA IGG, ACCESS RUBELLA IgG, ACCESS SYPHILIS, ACCESS TOXO IGM II, ACCESS TOXO IgG, ACCESS TOXO IgM II, Anti-HIV Antibody ASR 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 |
|---|---|---|---|---|---|---|
| December 28, 2017 | K171061 | MRSASelect II | JSO | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| November 6, 2012 | K122187 | VRESELECT CULTURE MEDIUM | JSO | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| January 13, 2011 | K093678 | PLATELIA ASPERGILLUS EIA MODEL 62793 | NOM | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| October 29, 2009 | K092355 | MONOLISA ANTI-HAV EIA | LOL | Substantially Equivalent | Bio-Rad Laboratories, Inc. | accessdata.fda.gov |
| October 29, 2009 | K092353 | MONOLISA ANTI-HAV IGM EIA | LOL | Substantially Equivalent | Bio-Rad Laboratories, Inc. | accessdata.fda.gov |
| July 1, 2009 | K090847 | PLATELIA TOXO IGM KIT MODEL 26211 | LGD | Substantially Equivalent | Bio-Rad Laboratories | accessdata.fda.gov |
| May 3, 2007 | K063319 | MONOLISA ANTI-HAV IGM EIA | LOL | Substantially Equivalent | Bio-Rad Laboratories | accessdata.fda.gov |
| May 3, 2007 | K063318 | MONOLISA ANTI-HAV EIA | LOL | Substantially Equivalent | Bio-Rad Laboratories | accessdata.fda.gov |
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Updated December 28, 2017. 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.