BK251274- RegenBMC® (RegenKit®-THT®-BMC)
510(k) Number: BK251274
Applicant: Regen Lab, USA, LLC
Device Name: RegenBMC® (RegenKit®-THT®-BMC)
Decision Date: 05/29/2026
Recall Alert
An update on the Cyclospora outbreak available here.
An update on the Cyclospora outbreak available here.
510(k) Number: BK251274
Applicant: Regen Lab, USA, LLC
Device Name: RegenBMC® (RegenKit®-THT®-BMC)
Decision Date: 05/29/2026