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Data / Medical devices / United States / Cancer Diagnostics, Inc.

Cancer Diagnostics, Inc.: FDA-registered device maker in Durham, NC, United States, 1 510(k) clearance

Cancer Diagnostics, Inc. is registered with the FDA (registration 3007496191) in Durham, NC, United States. It lists 45 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 10, 1990. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3007496191
Address
116 Page Point Circle, Durham, NC, United States, 27703
Owner or operator
Cancer Diagnostics, Inc. (10027057)
Roles
Manufacturer, Repackager or relabeler, Specification developer
First device listed
September 22, 2008
Registered through
2026
Brand names listed
AFB Stain Kit, Affinitiy Hematoxylin, Alcian Blue PAS Stain Kit, Alcian Blue pH 1 Stain Kit, Alcian Blue pH 2.5 Stain Kit, Alcian Blue, Certified 25 gm, Alcian Blue, pH 1, 1 qt, Alcian Blue, pH 2.5, 1 qt and more

Devices it lists

DeviceProduct codeClassRoleSource
Acid, PeriodicKKS1Repackager or relabeleraccessdata.fda.gov
Agent, ClearingKEM1Manufactureraccessdata.fda.gov
Alcian BlueIDA1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Blade, ScalpelGES1Repackager or relabeleraccessdata.fda.gov
Cassettes, TissueIDZ1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Container, EmbeddingKER1Manufactureraccessdata.fda.gov
Container, Specimen Mailer And Storage, Non-SterileNNK1Repackager or relabeleraccessdata.fda.gov
Coverslips, Microscope SlideKES1Repackager or relabeleraccessdata.fda.gov
Crystal Violet For HistologyICF1Manufactureraccessdata.fda.gov
CuretteHTF1Repackager or relabeleraccessdata.fda.gov
Eosin YHYB1Manufactureraccessdata.fda.gov
Filters, Cell Collection, Tissue ProcessingKET1Repackager or relabeleraccessdata.fda.gov
Fixative, Acid ContainingLDW1Manufactureraccessdata.fda.gov
Fixative, Alcohol ContainingLDZ1Manufactureraccessdata.fda.gov
Fixative, Formalin-ContainingLDY1Manufactureraccessdata.fda.gov
Fluid, Bouin'SIGN1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Formaldehyde (Formalin, Formol)IGG1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Formalin, Neutral BufferedIFP1Manufactureraccessdata.fda.gov
Formulations, Paraffin, AllKEO1Manufactureraccessdata.fda.gov
General Purpose ReagentPPM1Manufactureraccessdata.fda.gov
Handle, ScalpelGDZ1Repackager or relabeleraccessdata.fda.gov
HematoxylinHYJ1Manufactureraccessdata.fda.gov
Hematoxylin Harris'SHYK1Manufactureraccessdata.fda.gov
Hematoxylin Mayer'SHYL1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Media, Mounting, Water SolubleKEQ1Manufactureraccessdata.fda.gov
Microtome, AccessoriesIDL1Repackager or relabeleraccessdata.fda.gov
Mounting MediaLEB1Manufacturer, Repackager or relabeleraccessdata.fda.gov
MucicarmineHZC1Manufactureraccessdata.fda.gov
Orange GHZH1Manufactureraccessdata.fda.gov
Preservative, CytologicalLEA1Manufactureraccessdata.fda.gov
Products, Red-Cell Lysing ProductsGGK1Repackager or relabeleraccessdata.fda.gov
Punch, SurgicalLRY1Repackager or relabeleraccessdata.fda.gov
Reagent, SchiffHZT1Manufactureraccessdata.fda.gov
Scalpel, One-PieceGDX1Repackager or relabeleraccessdata.fda.gov
Slides, MicroscopeKEW1Repackager or relabeleraccessdata.fda.gov
Solution, Decalcifier, Acid ContainingKDX1Manufactureraccessdata.fda.gov
Solution, Formalin-Alcohol-Acetic AcidIGF1Manufactureraccessdata.fda.gov
Spatula, Cervical, CytologicalHHT2Specification developeraccessdata.fda.gov
Specimen/Tissue, Identification OrientationMJI1Manufactureraccessdata.fda.gov
Sprays, Synthetic, SmearIFI1Manufactureraccessdata.fda.gov
Stains, Chemical SolutionLED1Manufactureraccessdata.fda.gov
Stains, Dye PowderLEF1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Stains, Dye SolutionLEE1Manufactureraccessdata.fda.gov
Stains, HematologyKQC1Manufactureraccessdata.fda.gov
Tape, Measuring, Rulers And CalipersFTY1Repackager 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
September 10, 1990K902591CYTETTE(TM) CYTOLOGY BRUSHHHTSubstantially EquivalentBirchwood Laboratories, Inc.accessdata.fda.gov

Compare with other makers

Updated September 10, 1990. 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.