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Data / Medical devices / United States / Smart Practice

Smart Practice: FDA-registered device maker in Phoenix, AZ, United States, 4 510(k) clearances

Smart Practice is registered with the FDA (registration 2083595) in Phoenix, AZ, United States. It lists 8 device types. The FDA files 4 510(k) clearances under its listings, the newest dated December 19, 2012. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number
2083595
Address
3400 East Mcdowell RD., Phoenix, AZ, United States, 85008
Owner or operator
SMART PRACTICE (2083595)
Roles
Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
First device listed
February 12, 2007
Registered through
2026
Brand names listed
Finn Chamber FLAT PATCH, Finn Chambers, Finn Chambers Aqua, SmartPractice Skin Marker, allergEAZE, allergEAZE clear, patchProtect

Devices it lists

DeviceProduct codeClassRoleSource
Applicator, Absorbent Tipped, Non-SterileKXF1Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseLXG1Complaint file establishment, Repackager or relabeler, Specification developeraccessdata.fda.gov
Flask, Tissue CultureKJA1Complaint file establishment, Repackager or relabeler, Specification developeraccessdata.fda.gov
Marker, SkinFZZ1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Micro PipetteJRC1Complaint file establishment, Repackager or relabeler, Specification developeraccessdata.fda.gov
System, Suspension, Cell CultureKJF1Complaint file establishment, Repackager or relabeler, Specification developeraccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Complaint file establishment, Repackager or relabeler, Specification developeraccessdata.fda.gov
Tissue Culture, Accessories, DentalNVG1Complaint 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
December 19, 2012K123184FINN CHAMBERS AQUAKXFSubstantially EquivalentSmartpracticeaccessdata.fda.gov
March 15, 2011K103409ALLERGEAZE R CLEARKXFSubstantially EquivalentSmartpracticeaccessdata.fda.gov
December 22, 2006K063160ALLERGEAZE PATCH TEST CHAMBERSKXFSubstantially EquivalentSmartpracticeaccessdata.fda.gov
January 30, 2002K013820FINN CHAMBER (R)KXFSubstantially EquivalentEpitest Ltd. OYaccessdata.fda.gov

Compare with other makers

Updated December 19, 2012. 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.