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Newly Approved Waived Testing List from FDA

2007 | 2006 |

2007
  1. SelectDXImmunochemicalFOB.K060463.A1 Mar07.pdf
  2. AbaxisPiccoloChemistryAnalyzer.UricAcid.K931592.A3 Mar07.pdf
  3. AbaxisPiccoloChemistryAnalyzer.13Panel.K950164.A3 Mar07.pdf
  4. AbaxisPiccoloChemistryAnalyzer.BUNCreat.K9427822.A4 Mar07.pdf
  5. JantPharmacalCorpAccutestTSH.K990658.A4 Mar07.pdf
  6. WolfeRealityCheckIntegrSpeciCup.K050878.A6 Mar07.pdf
  7. DrugDetectDeviceScreenerDipDrugTestKO.K050878.A7 Mar07.pdf
  8. RedwoodToxilabRedtest6Cassette.K050050.A9 Mar07.pdf
  9. InnovaconE-ZSplitKeyCupII.K0500878.A9 Mar07.pdf
  10. RedwoodToxLabRedtestHomeDrugTest.K050878.A10 Mar07.pdf
  11. InvernessClearviewHpyloriTest.K024350.A11 Mar07.pdf
  12. Medi-LabSTREP.A.TWIST.RAPID.K023766.A20 Mar07.pdf
  13. InvernessClearviewStrepAExactIIDipstick.K010582.A24 Mar07.pdf
  14. MckessonMedi-LabStrepADipstick.K0582.A26 Mar07.pdf
  15. ImmunoDetectorBioSignMono.X07007 Mar07.pdf
  16. RocheDxCoaguChekxs.K060978.a1_ Apr07.pdf
  17. CholestechLDX.LipidProfileALT.GPT.K922612.A3 Jun07.pdf
  18. ArkraySPOTCHEM.EZ.SpotchemII.BasicPanel.K053401.A3 Jun07.pdf
  19. ArkraySPOTCHEM.EZ.creat.K050652.A3 Jun07.pdf
  20. ImmunoDetectorMono.WB.K961024.A5 Jun07.pdf
  21. FisherSureVueH.pyloriTest.K024350.A12 Jun07.pdf
  22. McKessonMediLabPerformance.pyloriTest.K024350.A13 Jun07.pdf
  23. CardinalHealthSPRapidTestMonoWB.K042272.A14 Jun07.pdf
  24. MckessonPerformStrepATestTwist.K023766.A19 Jun07.pdf
  25. PerMaximRediscreenStrepATwistCassette.K023766.A20 Jun07.pdf
  26. FertellMaleFertilityTest.K041039_Jun07.pdf
  27. ForsureOneStepFOBScreenCardTest.K06393_Jun07.pdf
  28. PolymedcoPolyStatH.Pylori.HScheinOne Step.K024350.A17_Jul07.pdf

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2006
  1. 06-146 Radiometer Membrane Aug06.doc
  2. HemoCue.Hb301.K061047.A1 Oct06.pdf
  3. GenzymeDx.OSOMBVBLUE.K050755 Oct06.pdf
  4. Arkray.SPOTCHEM.EZ.AST.K041427.A006 Oct06.pdf
  5. ArkraySPOTCHEM.EZ .Urea.K050077.A004 Oct06.pdf
  6. PiccoloPOCLiverPanelPlusRgt.K942782.A003 Oct06.pdf
  7. LittleNellLabsThyroChekTSH.K990658.A003 Oct06.pdfc
  8. BiositeTriageMeterpro.K021317.A008_Oct 06.pdf
  9. Clarity.Hpylori.Rapid.K024350.A9_Oct06.pdf
  10. BrananMedCorp FasToxMultipleDrugDipcard K023489 A2 Nov06.pdf
  11. BrananMedCorp QuickToxDrugScreenDipcard K022355 A4 Nov06.pdf
  12. Inverness BioStar Acceava StrepA K010582 A22 Nov06.pdf

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