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JPI — Device, Hematocrit Measuring Class II

FDA Device Classification

Classification Details

Product Code
JPI
Device Class
Class II
Regulation Number
864.6400
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K183680abbott point of carei-STAT CHEM8+ cartridge with the i-STAT 1 SystemFebruary 28, 2020
K163342abbott laboratoriesi-STAT Hematocrit test with i-STAT Alinity SystemAugust 22, 2017
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K924167noninvasive medical technologyCRIT-LINEMay 7, 1993
K903698statspin technologiesSTATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBESSeptember 17, 1990
K902028norfolk scientificSTATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READERJune 20, 1990
K870511norfolk scientificCHART-TYPE MICRO HEMATOCRIT TUBE READERMarch 16, 1987
K852482em diagnostic systemsMICROSPIN MINICENTRIFUGE ITEM NO. 65204/94July 15, 1985
K852516whittaker general medicalCENTIFUGE, HEMATOCRIT & MICROSEDIMENTATION COMBINEJuly 15, 1985
K850391hans j. brouwers and assocPLASMA EXTRACTION SYSTEMMay 10, 1985
K840767heraeus-christHAEMOFUGE A. BIOFUGE A. & BApril 17, 1984
K831318worthington diagnostic systemsCOMPUR* M1100 HEMATRCRIT SYSTEMJune 8, 1983
K830578fisher scientific coMICROHEMATOCRIT READERMarch 24, 1983
K823558fisher scientific coMICRO-HEMATOCRIT CENTRIFUGE 335/336January 21, 1983
K822716biodynamicsUNIVERSAL CENTRIFUGESeptember 30, 1982