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
Clearances under product code JPK — page 2
101–192 of 192- K871067 — MSI HEMATOLOGY CONTROL +
- K863224 — HEMATALL-C PLUS HEMATOLOGY CONTROLS
- K862318 — FISHER DIAGNOSTICS HEMATALL-C CALIBRATOR
- K862186 — LYPHOCHEK GLYCATED HEMOGLOBIN/WHOLE BLOOD/LEV.I&II
- K860751 — VON WILLEBRAND FAC. DEFIC. ABNORMAL CONTROL PLASMA
- K854353 — PLATELET-TROL II
- K852992 — PARA CHECK (AKA EIGHT CHECK-C)
- K853776 — MSI-HB HEMOGLOBIN CONTROL
- K852372 — CELL-DYN BRAND HEMATOLOGY REAGENTS
- K851663 — QUICK-COUNT HEMATOLOGY CONTROLS
- K851375 — TRI-COUNT
- K850755 — CBC-PLT-4/MULTIPLE WHOLE BLOOD HEMATOLOGY CONTROL
- K850250 — TECHNICON TESTPOINT ASSAYED HEMATOLOGY LOW & HIGH
- K844897 — HEMATOLOGY CONTROL UNI-CELL 5, UNI-CELL 7 & 8
- K844927 — QUANTICEL HHR + TWO HUMAN HEMATOLOGY W/PLATELETS
- K844928 — QUANTICEL HHR TWO HUMAN HEMATOLOGY REFERENCE
- K843805 — COULTER CHECK SAMPLE UNASSAYED HEMATOLOG
- K843485 — TRI-COUNT LASER
- K841809 — COUNT-A-PART PLUS
- K843962 — CBC-PLT-4 WHOLE BLOOD CONTROL/MULTIPLE
- K843093 — RETIC-CHEX
- K842286 — DIA T1, T2 & T3
- K841531 — PARA-TEK
- K842109 — TECHNICON TEST POINT ASSAYED HEMATOLOGY
- K842440 — SICKLE CELL STAT A/S HETEROZYGOUS-ERYTH
- K842017 — PARA 4
- K841239 — ASSIGNED VALUE FOR MEAN PLATELET
- K840302 — PLT - 4 PLATELET
- K834371 — TRI-COUNT 10
- K833563 — HC PLUS
- K834043 — MSI-HC HEMATOLOGY CONTROL
- K833130 — TRI-COUNT 7
- K831704 — TECHNICON H6000 SYSTEM CONTROL
- K830864 — WHITE BLOOD CELL CONTROL
- K831094 — PARA LASAR
- K820731 — HEMATALL-C PLUS HEMATOLOGY CONTROLS
- K820400 — ORTHO* HEMATOLOGY CONTROL 8 NORMAL
- K820401 — ORTHO* HEMATOLOGY CONTR. 8 ABN. HI/LOW
- K812237 — HEMOTOLOGY QUALITY CONTROL MIXTURE
- K812280 — HEMATOLOGY CONTROL
- K812357 — VENTREX DATA REDUCTION & QUAL. CONTR. SY
- K810756 — HEMOTOLOGY QUALITY CONTROL MIXTURES
- K801054 — THROMBO-TEST (X)
- K803073 — ORTHO HEMATOLOGY CONTROL
- K803083 — ORTHO HEMOTOLOGY CONTROL-NORMAL
- K803084 — ORTHO HEMATOLOGY CONTROL ABNORMAL LOW
- K802265 — CBC PLT-4
- K802267 — PLT-4 SIZE-CHECK
- K802141 — CH-60 PLUS WHOLE BLOOD PLATELET CONTROL
- K802142 — CH-60 PLUS WHOLE BLOOD PLATELET/ABNORNAL
- K802143 — CH-60 PLUS /ABNORMAL LOW/BLOOD PLATELET
- K801265 — WHITE BLOOD CELL COUNT CONTROL LEVELS
- K801267 — RED BLOOD CELL COUNT & HEMATOCRIT CNTL
- K800938 — TRI-CHECK
- K800780 — SANDARE LYOPHILIZED HEMOGLOBIN CONTROLS
- K800361 — HEMATO-CHEX
- K792606 — WHOLE BLOOD PLATELET CONTROL NORMAL,
- K792467 — PLATELET-CHEX FOR BLOOD CENTERS
- K792209 — SANDARE HEMOGLOBIN CONTROLS
- K792055 — FISHER DIAGNOSTICS HEMATOLOGY CONTROLS
- K791750 — COUNTER-CHECK PLUS
- K791772 — COUNTER-CHECK PLUS NORMAL, HIGH ABN.
- K791226 — PLATELET-CHEX PLUS
- K791227 — PARA-7
- K791228 — PARA-8
- K791030 — HEMOGLOBIN AF/SC ELECTROPHORESIS CONTROL
- K790826 — COAGULATION ARP
- K790415 — HCP-7
- K790457 — HEMOGLOBIN CONTROLS
- K790525 — HEMATROL S HEMATOLOGY CONTROLS
- K781969 — BLOOD, HEMATOLOGY REFERENCE CONTROL
- K781745 — QUANTICEL HHR, L531 AND L532
- K781786 — QUANTICEL HHR # L500 AND L501
- K781572 — NORMAL HEMATOLOGY CONTROL UNASSAYED
- K781573 — ABNORMAL HEMATOLOGY CONTROL UNASSAYED
- K781247 — QUANTICEL-HRP
- K780980 — PLATELET CONTROL
- K781077 — CONTROL, HEMATOLOGY, CH-60
- K780835 — ARANTROL
- K780714 — PLATELET CONTROL
- K780140 — CELL-CHEX
- K772195 — HEMATOLOGY REFERENCE CONTROLS
- K771753 — HEMATOLOGY REFERENCE CONTROL
- K770384 — MNITROL HEMOTOL. REF. AND CONTROL
- K770386 — LATELET, CONTROL, NORMAL & ABNORMAL
- K770095 — PLATELET CONTROL, NORMAL & ABNORMAL
- K770020 — PLATELET-CHEX-HUMAN
- K760549 — PLATELET CONTROLS, NORMAL & ABNORMAL
- K760596 — BIOTROL-ABNORMAL
- K760597 — BIOTROL-NORMAL
- K760682 — 4C ABNORMAL LOW-HIGH (8 X 6 M1)
- K760162 — HEMATOLOGY CONTROL
Data sourced from openFDA. This site is unofficial and independent of the FDA.