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Data / Medical devices / United States / Jubilant Hollisterstier LLC

Jubilant Hollisterstier LLC: FDA-registered device maker in Spokane, WA, United States, 1 510(k) clearance

Jubilant Hollisterstier LLC is registered with the FDA (registration 3030554525) in Spokane, WA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 13, 1995. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3030554525
FEI number
3010477
Address
3525 N Regal St, Spokane, WA, United States, 99207
Owner or operator
JUBILANT HOLLISTERSTIER LLC (9038322)
Roles
Manufacturer, Specification developer
First device listed
April 8, 1996
Registered through
2026
Brand names listed
ComforTen Skin Test Device, Prick Lancetter, Quintest Skin Test Device, Quintip Skin Test Device

Devices it lists

DeviceProduct codeClassRoleSource
Allergen And Vaccine Delivery NeedlesSCL2Manufacturer, Specification developeraccessdata.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
November 13, 1995K953939QUINTESTSCLSubstantially EquivalentBayer Corp.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
April 20, 200635212Not yet classifiedTerminatedSterile empty vials, 10mL/20mm closure sold 25/case. Label on vial states STERILE EMPTY VIAL Hollister-Stier Laboratories LLC Spokane, WA 99207 USA. Labels on case states 25 STERILE EMPTY VIALS 10 mL/20mm Closure CAUTIONPotential for vials to be cracked at the vial stopper interface. This could compromise the sterility of the products compounded into the vials.accessdata.fda.gov

Compare with other makers

Updated May 17, 2006. 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.