Product code JPK— Hematology
XN CHECK
- Classification name
- Mixture, Hematology Quality Control
- Device class
- Class 2
- Regulation
- 21 CFR 864.8625
- Advisory panel
- Hematology
- Total cleared
- 192
- First cleared
- Most recent
Market context for product code JPK
FDA has cleared devices under product code JPK between 1976 and 2016, filed by 50 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2016
- 2014
- 2013
- 2012
- 2011
- 2010
- 2009
- 2007
- 2006
- 2005
- 2004
- 2003
- 2002
- 2001
- 2000
Top applicants under product code JPK
Recent clearances under product code JPK
1–100 of 192- K160586 — XN-L CHECK
- K160588 — XN CHECK BF
- K160590 — XN CHECK
- K160606 — BC-5D Hematology Control
- K141957 — XN CHECK BF
- K141964 — XN CHECK
- K130962 — R&D 5D RETIC HEMATOLOGY CONTROL
- K120742 — XN CHECK
- K120744 — XN CHECK BF
- K101578 — R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL
- K100790 — COULTER LIN-X LINEARITY CONTROL, MODEL A81196
- K100607 — COULTER 4C-EX 300 CELL CONTROL
- K091303 — LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV
- K100050 — R & D SYSTEMS XERET HEMATOLOGY CONTROL
- K091433 — R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL
- K090201 — UA-CELLULAR FOR IQ
- K082162 — COULTER BODY FLUID CONTROL
- K081822 — COULTER 6C CELL CONTROL, MODELS 628027 & A59925
- K081641 — COULTER LIN-X LINEARITY CONTROL
- K073178 — HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004
- K072846 — CSF AUTOMATED CONTROL, MODELS CSF001, CSF003
- K072268 — HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S
- K072096 — CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04
- K070199 — RETIC-CHEX LINEARITY FOR BC
- K063218 — E-CHECK (XE)
- K061511 — R&D CBC-3D + CRP HEMATOLOGY CONTROL
- K061320 — R&D LH-NRBC HEMATOLOGY CONTROL
- K061064 — COULTER LIN-C LINEARITY CONTROL, MODELS 7547065, 723503
- K060464 — COULTER 5C CELL CONTROL
- K053362 — CELL-CHEX AUTO
- K051706 — IQ BODY FLUIDS CONTROL
- K051339 — R&D CBC-4K PLUS RETICS HEMATOLOGY CONTROL
- K050721 — ABX ERYTROL
- K042836 — LIQUICHEK RETICULOCYTE CONTROL (A)
- K042587 — RETIC-CHEX FOR CELL-DYN
- K042336 — METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK
- K042094 — R&D CBC-XE HEMATOLOGY CONTROL
- K041457 — LIQUICHEK HEMATOLOGY CONTROL (A)
- K024173 — CDS 3-PD HEMATOLOGY CONTROLS
- K022968 — ADVIA TESTPOINT CSF CONTROL
- K021922 — MODIFICATION TO PARA 5X
- K020229 — R & D BODY FLUID CONTROL
- K013898 — R&D RET-LINE KIT
- K013842 — IMMUNO-TROL LOW CELLS
- K011410 — PARA 5X
- K010470 — R & D 4K RETIC
- K010461 — ADVIA RETIC PLUS
- K010598 — SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL
- K010409 — CBC-SF
- K010064 — 4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190
- K010066 — 5C-ES CELL CONTROL, MODELS 7547191, 7547192
- K003874 — CBC-4K HEMATOLOGY CONTROL
- K003534 — PENTRA 5D
- K003208 — R & D 3K RETIC
- K002511 — FETALTROL
- K000115 — RETIC CHEX LINEARITY
- K993496 — RETIC-QUINOX
- K991876 — SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE
- K984216 — IMMUNO-TROL CONTROL CELLS
- K983032 — CBC-5D HEMATOLOGY CONTROL
- K984099 — QBC CENTRIFUGAL HEMATOLOGY CONTROL
- K972170 — ESR CONTROL-HC HEMATOLOGY ERYTHROCYTE SEDIMENTATION
- K972172 — ESR CONTROL-M HEMATOLOGY ERYTHROCYTE SEDIMENTATION
- K971469 — COULTER ACT TRON CELL CONTROL
- K970331 — CBC-4K HEMATOLOGY CONTROL
- K961673 — R&D RETIC-PG HEMATOLOGY CONTROL
- K960557 — CALIBRATION VERIFICATION ASSESSMENT (CVA)
- K960471 — TRI-COUNT 20
- K960005 — TRI-COURT 20-T
- K955334 — COULTER LINEARITY CONTROL
- K955016 — 4C PLUS COULTER CELL CONTROL
- K954137 — QBC CENTRIFUGAL HEMATOLOGY CONTROL
- K952720 — AALTO SCIENTIFIC LTD. GLYCATED HEMOGLOBIN CONTROL LEVELS I & II
- K952245 — SF-CHECK
- K941965 — EZ-RANGE
- K943335 — RETIC CONTROL-M HEMATOLOGY CONTROL/MULTIPLE
- K943336 — RETIC CONTROL-H HEMATOLOGY CONTROL/MULTIPLE
- K944751 — COULTER FLOW SET
- K942822 — CBC-LINE HEMATOLOGY LINEARITY CONTROL
- K935196 — PARA 5 DIFF
- K940089 — CBC-COBAS 5 HEMATOLOGY CONTROL/MULTIPLE
- K940181 — SE-CHECK
- K935343 — CENTRIFIQ BLOOD CONTROL
- K931947 — CHECKPOINT
- K930119 — COULTER RETIC-C CELL CONTROL
- K923971 — QC-CHEX
- K914099 — GAS TRAK CONNECT BLOOD GAS CONTROL
- K913879 — CBC-8K(TM) HEMATOLOGY CONTROL/MULTIPLE
- K912133 — PX COULTER(R) CELL CONTROL
- K905524 — RETIC-CHEX
- K904637 — QBC(R) CENTRIFUGAL HEMATOLOGY CONTROL/MULTIPLE
- K904461 — METER TRAX
- K904464 — CBC-LASER(R) HEMATOLOGY CONTROL/MULTIPLE-MODIFIED
- K900017 — REP GLYCO CONTROL NORMAL(3209) AND ABNORMAL(3210)
- K893895 — HEMATOLOGY CONTROL MIXTURES FOR QUALITY CONTROL
- K884266 — PH BLOOD GAS CONTROL PRODUCTS
- K890767 — NE-CHECK
- K890749 — CBC-TECH (TM) HEMATOLOGY CONTROL/MULTIPLE
- K880270 — MSI-DIFF PLUS
- K873354 — QBC VENOUS BLOOD CONTROL/MULTIPLE
Data sourced from openFDA. This site is unofficial and independent of the FDA.