Panels › Hematology › Product code JPK · Class 2
Mixture, Hematology Quality Control
Regulation 864.8625
0510(k)s in 12 months (192 all time)
0recalls in 12 months (16 all time)
15recalls that name a 510(k)
Top companies in JPK
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 25, 1987 | K871067 | MSI HEMATOLOGY CONTROL + Medical Specialties, Inc. | JPK |
| Oct 29, 1986 | K863224 | HEMATALL-C PLUS HEMATOLOGY CONTROLS Fisher Scientific Co., LLC | JPK |
| Jul 10, 1986 | K862318 | FISHER DIAGNOSTICS HEMATALL-C CALIBRATOR Fisher Scientific Co., LLC | JPK |
| Jul 1, 1986 | K862186 | LYPHOCHEK GLYCATED HEMOGLOBIN/WHOLE BLOOD/LEV.I&II Bio-Rad | JPK |
| Mar 18, 1986 | K860751 | VON WILLEBRAND FAC. DEFIC. ABNORMAL CONTROL PLASMA Bio/Data Corp. | JPK |
| Nov 26, 1985 | K854353 | PLATELET-TROL II R&D Systems, Inc. | JPK |
| Oct 10, 1985 | K852992 | PARA CHECK (AKA EIGHT CHECK-C) Streck Laboratories, Inc. | JPK |
| Sep 19, 1985 | K853776 | MSI-HB HEMOGLOBIN CONTROL Medical Specialties, Inc. | JPK |
| Sep 3, 1985 | K852372 | CELL-DYN BRAND HEMATOLOGY REAGENTS Abbott Diagnostics | JPK |
| Jul 23, 1985 | K851663 | QUICK-COUNT HEMATOLOGY CONTROLS Seragen Diagnostics, Inc. | JPK |
| Jul 12, 1985 | K851375 | TRI-COUNT Hematology Marketing Assoc. | JPK |
| May 13, 1985 | K850755 | CBC-PLT-4/MULTIPLE WHOLE BLOOD HEMATOLOGY CONTROL R&D Systems, Inc. | JPK |
| Apr 1, 1985 | K850250 | TECHNICON TESTPOINT ASSAYED HEMATOLOGY LOW & HIGH Technicon Instruments Corp. | JPK |
| Mar 22, 1985 | K844928 | QUANTICEL HHR TWO HUMAN HEMATOLOGY REFERENCE Bhp Diagnostix, Inc. | JPK |
| Mar 22, 1985 | K844927 | QUANTICEL HHR + TWO HUMAN HEMATOLOGY W/PLATELETS Bhp Diagnostix, Inc. | JPK |
| Mar 22, 1985 | K844897 | HEMATOLOGY CONTROL UNI-CELL 5, UNI-CELL 7 & 8 Medical Specialties Laboratories | JPK |
| Dec 17, 1984 | K843805 | COULTER CHECK SAMPLE UNASSAYED HEMATOLOG Coulter Electronics, Inc. | JPK |
| Dec 12, 1984 | K843485 | TRI-COUNT LASER Hematology Marketing Assoc. | JPK |
| Nov 30, 1984 | K841809 | COUNT-A-PART PLUS Diagnostic Technology, Inc. | JPK |
| Nov 1, 1984 | K843962 | CBC-PLT-4 WHOLE BLOOD CONTROL/MULTIPLE R&D Systems, Inc. | JPK |
| Oct 23, 1984 | K843093 | RETIC-CHEX Streck Laboratories, Inc. | JPK |
| Sep 11, 1984 | K842286 | DIA T1, T2 & T3 Diatech, Inc. | JPK |
| Jul 27, 1984 | K842440 | SICKLE CELL STAT A/S HETEROZYGOUS-ERYTH Anco Medical Reagents & Assoc. | JPK |
| Jul 27, 1984 | K842109 | TECHNICON TEST POINT ASSAYED HEMATOLOGY Technicon Instruments Corp. | JPK |
| Jul 27, 1984 | K841531 | PARA-TEK Streck Laboratories, Inc. | JPK |
| Jun 26, 1984 | K842017 | PARA 4 Streck Laboratories, Inc. | JPK |
| May 2, 1984 | K841239 | ASSIGNED VALUE FOR MEAN PLATELET Coulter Electronics, Inc. | JPK |
| Mar 12, 1984 | K840302 | PLT - 4 PLATELET R&D Systems, Inc. | JPK |
| Mar 9, 1984 | K834371 | TRI-COUNT 10 Hematology Marketing Assoc. | JPK |
| Jan 3, 1984 | K834043 | MSI-HC HEMATOLOGY CONTROL Medical Specialties, Inc. | JPK |
| Jan 3, 1984 | K833563 | HC PLUS Coulter Electronics, Inc. | JPK |
| Oct 20, 1983 | K833130 | TRI-COUNT 7 Hematology Marketing Assoc. | JPK |
| Jul 6, 1983 | K831704 | TECHNICON H6000 SYSTEM CONTROL Technicon Instruments Corp. | JPK |
| Jun 15, 1983 | K830864 | WHITE BLOOD CELL CONTROL Control Diagnostics | JPK |
| Jun 8, 1983 | K831094 | PARA LASAR Streck Laboratories, Inc. | JPK |
| May 12, 1982 | K820731 | HEMATALL-C PLUS HEMATOLOGY CONTROLS Fisher Scientific Co., LLC | JPK |
| Mar 15, 1982 | K820401 | ORTHO* HEMATOLOGY CONTR. 8 ABN. HI/LOW Orhto Diagnostic Systems, Inc. | JPK |
| Mar 15, 1982 | K820400 | ORTHO* HEMATOLOGY CONTROL 8 NORMAL Ortho Diagnostic Systems, Inc. | JPK |
| Sep 9, 1981 | K812280 | HEMATOLOGY CONTROL American Dade | JPK |
| Sep 9, 1981 | K812237 | HEMOTOLOGY QUALITY CONTROL MIXTURE American Dade | JPK |
| Sep 1, 1981 | K812357 | VENTREX DATA REDUCTION & QUAL. CONTR. SY Ventrex Laboratories, Inc. | JPK |
| Jun 30, 1981 | K810756 | HEMOTOLOGY QUALITY CONTROL MIXTURES Scientific Standards, Inc. | JPK |
| Mar 13, 1981 | K801054 | THROMBO-TEST (X) Medtro GmbH | JPK |
| Dec 31, 1980 | K803084 | ORTHO HEMATOLOGY CONTROL ABNORMAL LOW Ortho Instruments | JPK |
| Dec 31, 1980 | K803083 | ORTHO HEMOTOLOGY CONTROL-NORMAL Ortho Instruments | JPK |
| Dec 31, 1980 | K803073 | ORTHO HEMATOLOGY CONTROL Ortho Instruments | JPK |
| Nov 12, 1980 | K802267 | PLT-4 SIZE-CHECK R&D Systems, Inc. | JPK |
| Nov 12, 1980 | K802265 | CBC PLT-4 R&D Systems, Inc. | JPK |
| Oct 10, 1980 | K802143 | CH-60 PLUS /ABNORMAL LOW/BLOOD PLATELET American Dade | JPK |
| Oct 10, 1980 | K802142 | CH-60 PLUS WHOLE BLOOD PLATELET/ABNORNAL American Dade | JPK |
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