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Data / Medical devices / United States / Belair Instrument Co, LLC D/B/A Avantik

Belair Instrument Co, LLC D/B/A Avantik: FDA-registered device maker in Pine Brook, NJ, United States, 1 510(k) clearance

Belair Instrument Co, LLC D/B/A Avantik is registered with the FDA (registration 3014680809) in Pine Brook, NJ, United States. It lists 11 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 12, 2010. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3014680809
Address
19 Chapin Road, Building C, Pine Brook, NJ, United States, 07058
Owner or operator
Belair Instrument Co, LLC d/b/a Avantik (10057530)
Roles
Complaint file establishment, Repackager or relabeler, Specification developer
First device listed
May 30, 2018
Registered through
2026
Brand names listed
Avantik Pipette Tip, Avantik QS12 Cryostat, Avantik Tissue Floatation Bath, Avantik VTM, Avantik VTM-Kit, Sante Pipette Tips

Devices it lists

DeviceProduct codeClassRoleSource
Applicator, Absorbent Tipped, SterileKXG1Complaint file establishmentaccessdata.fda.gov
Bath, Flotation, TissueIDY1Complaint file establishmentaccessdata.fda.gov
Cassettes, TissueIDZ1Complaint file establishment, Specification developeraccessdata.fda.gov
Coverslips, Microscope SlideKES1Complaint file establishmentaccessdata.fda.gov
Micro PipetteJRC1Complaint file establishmentaccessdata.fda.gov
Microtome, AccessoriesIDL1Complaint file establishmentaccessdata.fda.gov
Microtome, CryostatIDP1Complaint file establishmentaccessdata.fda.gov
Scalpel, One-PieceGDX1Complaint file establishmentaccessdata.fda.gov
Slides, MicroscopeKEW1Complaint file establishmentaccessdata.fda.gov
Supplement, Culture MediaJSK1Complaint file establishmentaccessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood CollectionJKA2Complaint file establishment, Repackager or relabeleraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
July 12, 2010K093910IMPROVACUTER GEL & CLOT ACTIVATOR TUBEJKASubstantially EquivalentGuangzhou Improve Medical Instruments Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated July 12, 2010. 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.