Mixture, Hematology Quality Control
FDA product code JPK · 190 cleared devices
Class 2
Hematology
- Regulation
- 21 CFR 864.8625
- Review panel
- HE
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1976-08-04 – 2016-12-22
JPK
1986-07-10
JPK
1986-07-01
LYPHOCHEK GLYCATED HEMOGLOBIN/WHOLE BLOOD/LEV.I&II
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JPK
1986-03-18
VON WILLEBRAND FAC. DEFIC. ABNORMAL CONTROL PLASMA
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JPK
1985-11-26
PLATELET-TROL II
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JPK
1985-10-10
PARA CHECK (AKA EIGHT CHECK-C)
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JPK
1985-09-19
MSI-HB HEMOGLOBIN CONTROL
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JPK
1985-09-03
CELL-DYN BRAND HEMATOLOGY REAGENTS
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JPK
1985-07-23
QUICK-COUNT HEMATOLOGY CONTROLS
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JPK
1985-07-12
TRI-COUNT
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JPK
1985-05-13
CBC-PLT-4/MULTIPLE WHOLE BLOOD HEMATOLOGY CONTROL
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JPK
1985-04-01
TECHNICON TESTPOINT ASSAYED HEMATOLOGY LOW & HIGH
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JPK
1985-03-22
QUANTICEL HHR TWO HUMAN HEMATOLOGY REFERENCE
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JPK
1985-03-22
QUANTICEL HHR + TWO HUMAN HEMATOLOGY W/PLATELETS
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JPK
1985-03-22
HEMATOLOGY CONTROL UNI-CELL 5, UNI-CELL 7 & 8
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JPK
1984-12-17
COULTER CHECK SAMPLE UNASSAYED HEMATOLOG
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JPK
1984-12-12
TRI-COUNT LASER
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JPK
1984-11-30
COUNT-A-PART PLUS
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JPK
1984-11-01
CBC-PLT-4 WHOLE BLOOD CONTROL/MULTIPLE
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JPK
1984-10-23
RETIC-CHEX
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JPK
1984-09-11
DIA T1, T2 & T3
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JPK
1984-07-27
SICKLE CELL STAT A/S HETEROZYGOUS-ERYTH
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JPK
1984-07-27
TECHNICON TEST POINT ASSAYED HEMATOLOGY
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JPK
1984-07-27
PARA-TEK
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JPK
1984-06-26
PARA 4
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JPK
1984-05-02
ASSIGNED VALUE FOR MEAN PLATELET
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JPK
1984-03-12
PLT - 4 PLATELET
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JPK
1984-03-09
TRI-COUNT 10
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JPK
1984-01-03
MSI-HC HEMATOLOGY CONTROL
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JPK
1984-01-03
HC PLUS
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JPK
1983-10-20
TRI-COUNT 7
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JPK
1983-07-06
TECHNICON H6000 SYSTEM CONTROL
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JPK
1983-06-15
WHITE BLOOD CELL CONTROL
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JPK
1983-06-08
PARA LASAR
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JPK
1982-05-12
HEMATALL-C PLUS HEMATOLOGY CONTROLS
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JPK
1982-03-15
ORTHO* HEMATOLOGY CONTR. 8 ABN. HI/LOW
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JPK
1982-03-15
ORTHO* HEMATOLOGY CONTROL 8 NORMAL
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JPK
1981-09-09
HEMATOLOGY CONTROL
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JPK
1981-09-09
HEMOTOLOGY QUALITY CONTROL MIXTURE
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JPK
1981-09-01
VENTREX DATA REDUCTION & QUAL. CONTR. SY
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JPK
1981-06-30
HEMOTOLOGY QUALITY CONTROL MIXTURES
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JPK
1981-03-13
THROMBO-TEST (X)
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JPK
1980-12-31
ORTHO HEMATOLOGY CONTROL ABNORMAL LOW
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JPK
1980-12-31
ORTHO HEMOTOLOGY CONTROL-NORMAL
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JPK
1980-12-31
ORTHO HEMATOLOGY CONTROL
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JPK
1980-11-12
PLT-4 SIZE-CHECK
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JPK
1980-11-12
CBC PLT-4
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JPK
1980-10-10
CH-60 PLUS /ABNORMAL LOW/BLOOD PLATELET
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JPK
1980-10-10
CH-60 PLUS WHOLE BLOOD PLATELET/ABNORNAL
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JPK
1980-10-10
CH-60 PLUS WHOLE BLOOD PLATELET CONTROL
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JPK
1980-07-14
RED BLOOD CELL COUNT & HEMATOCRIT CNTL
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JPK
1980-07-14
WHITE BLOOD CELL COUNT CONTROL LEVELS
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JPK
1980-05-08
TRI-CHECK
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JPK
1980-04-24
SANDARE LYOPHILIZED HEMOGLOBIN CONTROLS
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JPK
1980-04-04
HEMATO-CHEX
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JPK
1980-02-13
WHOLE BLOOD PLATELET CONTROL NORMAL,
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JPK
1979-12-31
PLATELET-CHEX FOR BLOOD CENTERS
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JPK
1979-12-04
SANDARE HEMOGLOBIN CONTROLS
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JPK
1979-11-05
FISHER DIAGNOSTICS HEMATOLOGY CONTROLS
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JPK
1979-10-11
COUNTER-CHECK PLUS NORMAL, HIGH ABN.
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JPK
1979-10-11
COUNTER-CHECK PLUS
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JPK
1979-08-03
PARA-8
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JPK
1979-08-03
PARA-7
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JPK
1979-08-03
PLATELET-CHEX PLUS
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JPK
1979-06-22
HEMOGLOBIN AF/SC ELECTROPHORESIS CONTROL
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JPK
1979-05-31
COAGULATION ARP
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JPK
1979-04-04
HEMOGLOBIN CONTROLS
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JPK
1979-04-04
HCP-7
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JPK
1979-04-03
HEMATROL S HEMATOLOGY CONTROLS
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JPK
1979-01-03
BLOOD, HEMATOLOGY REFERENCE CONTROL
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JPK
1978-11-15
QUANTICEL HHR # L500 AND L501
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JPK
1978-11-15
QUANTICEL HHR, L531 AND L532
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JPK
1978-10-17
ABNORMAL HEMATOLOGY CONTROL UNASSAYED
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JPK
1978-10-17
NORMAL HEMATOLOGY CONTROL UNASSAYED
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JPK
1978-09-14
QUANTICEL-HRP
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JPK
1978-07-27
CONTROL, HEMATOLOGY, CH-60
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JPK
1978-07-27
PLATELET CONTROL
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JPK
1978-06-22
ARANTROL
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JPK
1978-06-06
PLATELET CONTROL
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JPK
1978-03-27
CELL-CHEX
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JPK
1978-02-03
HEMATOLOGY REFERENCE CONTROLS
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JPK
1977-11-28
HEMATOLOGY REFERENCE CONTROL
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JPK
1977-04-08
MNITROL HEMOTOL. REF. AND CONTROL
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JPK
1977-03-21
LATELET, CONTROL, NORMAL & ABNORMAL
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JPK
1977-02-28
PLATELET CONTROL, NORMAL & ABNORMAL
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JPK
1977-02-16
PLATELET-CHEX-HUMAN
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JPK
1976-10-08
4C ABNORMAL LOW-HIGH (8 X 6 M1)
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JPK
1976-10-08
BIOTROL-NORMAL
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JPK
1976-10-08
BIOTROL-ABNORMAL
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JPK
1976-10-08
PLATELET CONTROLS, NORMAL & ABNORMAL
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JPK
1976-08-04
HEMATOLOGY CONTROL
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