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Data / Medical devices / United States / Drucker Diagnostics, LLC

Drucker Diagnostics, LLC: FDA-registered device maker in Philipsburg, PA, United States, 3 510(k) clearances

Drucker Diagnostics, LLC is registered with the FDA (registration 3011765035) in Philipsburg, PA, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 23, 1999. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3011765035
Address
200 Shady Ln Ste 170, Philipsburg, PA, United States, 16866
Owner or operator
DRUCKER DIAGNOSTICS (9078843)
Roles
Complaint file establishment, Manufacturer, Remanufacturer
First device listed
February 15, 2006
Registered through
2026
Brand names listed
614B CENTRIFUGE, 614L CENTRIFUGE, 614M CENTRIFUGE, 614VET CENTRIFUGE, 642B CENTRIFUGE, 642E CENTRIFUGE, 642M CENTRIFUGE, 642VES CENTRIFUGE and more

Devices it lists

DeviceProduct codeClassRoleSource
Centrifuges (Micro, Ultra, Refrigerated) For Clinical UseJQC1Complaint file establishment, Manufacturer, Remanufactureraccessdata.fda.gov
Counter, Differential CellGKZ2Complaint file establishment, Manufacturer, Remanufactureraccessdata.fda.gov
Tube, Collection, Capillary BloodGIO1Complaint file establishment, Manufactureraccessdata.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
September 23, 1999K992849QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEMGKZSubstantially EquivalentBd Becton Dickinson Vacutainer Systems Preanalyticaccessdata.fda.gov
May 17, 1996K960827QBC ACCUTUBE(423406)/QBC AUTOREAD(424571)GKZSubstantially EquivalentBecton Dickinson Diagnostic Instrument Systemsaccessdata.fda.gov
August 3, 1989K891276QBC MALARIA SYSTEMGKZSubstantially EquivalentBd Becton Dickinson Vacutainer Systems Preanalyticaccessdata.fda.gov

Compare with other makers

Updated September 23, 1999. 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.