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 |
|---|---|---|---|
| Feb 7, 2001 | K010064 | 4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190 Beckman Coulter, Inc. | JPK |
| Jan 12, 2001 | K003874 | CBC-4K HEMATOLOGY CONTROL R&D Systems, Inc. | JPK |
| Dec 1, 2000 | K003534 | PENTRA 5D R&D Systems, Inc. | JPK |
| Nov 7, 2000 | K003208 | R & D 3K RETIC R&D Systems, Inc. | JPK |
| Sep 11, 2000 | K002511 | FETALTROL Trillium Diagnostics, LLC | JPK |
| Mar 27, 2000 | K000115 | RETIC CHEX LINEARITY Streck Laboratories, Inc. | JPK |
| Nov 30, 1999 | K993496 | RETIC-QUINOX Hematronix, Inc. | JPK |
| Jun 17, 1999 | K991876 | SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE R&D Systems, Inc. | JPK |
| Mar 16, 1999 | K984216 | IMMUNO-TROL CONTROL CELLS Coulter Corp. | JPK |
| Feb 17, 1999 | K983032 | CBC-5D HEMATOLOGY CONTROL R&D Systems, Inc. | JPK |
| Dec 10, 1998 | K984099 | QBC CENTRIFUGAL HEMATOLOGY CONTROL R&D Systems, Inc. | JPK |
| Jul 24, 1997 | K972172 | ESR CONTROL-M HEMATOLOGY ERYTHROCYTE SEDIMENTATION R&D Systems, Inc. | JPK |
| Jul 24, 1997 | K972170 | ESR CONTROL-HC HEMATOLOGY ERYTHROCYTE SEDIMENTATION R&D Systems, Inc. | JPK |
| Jun 30, 1997 | K971469 | COULTER ACT TRON CELL CONTROL Coulter Corp. | JPK |
| Apr 16, 1997 | K970331 | CBC-4K HEMATOLOGY CONTROL R&D Systems, Inc. | JPK |
| Jul 15, 1996 | K961673 | R&D RETIC-PG HEMATOLOGY CONTROL R&D Systems, Inc. | JPK |
| Apr 3, 1996 | K960557 | CALIBRATION VERIFICATION ASSESSMENT (CVA) Streck Laboratories, Inc. | JPK |
| Mar 20, 1996 | K960471 | TRI-COUNT 20 Hematronix, Inc. | JPK |
| Mar 19, 1996 | K960005 | TRI-COURT 20-T Hematronix, Inc. | JPK |
| Feb 8, 1996 | K955334 | COULTER LINEARITY CONTROL Coulter Corp. | JPK |
| Jan 30, 1996 | K955016 | 4C PLUS COULTER CELL CONTROL Coulter Corp. | JPK |
| Oct 6, 1995 | K954137 | QBC CENTRIFUGAL HEMATOLOGY CONTROL R&D Systems, Inc. | JPK |
| Sep 20, 1995 | K952720 | AALTO SCIENTIFIC LTD. GLYCATED HEMOGLOBIN CONTROL LEVELS I & II Aalto Scientific, Ltd. | JPK |
| Sep 1, 1995 | K952245 | SF-CHECK Streck Laboratories, Inc. | JPK |
| Apr 25, 1995 | K941965 | EZ-RANGE Hematronix, Inc. | JPK |
| Dec 12, 1994 | K943336 | RETIC CONTROL-H HEMATOLOGY CONTROL/MULTIPLE R&D Systems, Inc. | JPK |
| Dec 12, 1994 | K943335 | RETIC CONTROL-M HEMATOLOGY CONTROL/MULTIPLE R&D Systems, Inc. | JPK |
| Dec 8, 1994 | K944751 | COULTER FLOW SET Coulter Corp. | JPK |
| Oct 7, 1994 | K942822 | CBC-LINE HEMATOLOGY LINEARITY CONTROL R&D Systems, Inc. | JPK |
| Apr 5, 1994 | K935196 | PARA 5 DIFF Streck Laboratories, Inc. | JPK |
| Mar 22, 1994 | K940089 | CBC-COBAS 5 HEMATOLOGY CONTROL/MULTIPLE R&D Systems, Inc. | JPK |
| Mar 9, 1994 | K940181 | SE-CHECK Streck Laboratories, Inc. | JPK |
| Jan 27, 1994 | K935343 | CENTRIFIQ BLOOD CONTROL Hematronix, Inc. | JPK |
| Jun 18, 1993 | K931947 | CHECKPOINT Medical Specialties, Inc. | JPK |
| Apr 5, 1993 | K930119 | COULTER RETIC-C CELL CONTROL Coulter Electronics, Inc. | JPK |
| Nov 16, 1992 | K923971 | QC-CHEX Streck Laboratories, Inc. | JPK |
| Dec 18, 1991 | K914099 | GAS TRAK CONNECT BLOOD GAS CONTROL Biochemical Sciences, Inc. | JPK |
| Nov 27, 1991 | K913879 | CBC-8K(TM) HEMATOLOGY CONTROL/MULTIPLE R&D Systems, Inc. | JPK |
| Jul 17, 1991 | K912133 | PX COULTER(R) CELL CONTROL Coulter Electronics, Inc. | JPK |
| Feb 20, 1991 | K905524 | RETIC-CHEX Streck Laboratories, Inc. | JPK |
| Oct 29, 1990 | K904637 | QBC(R) CENTRIFUGAL HEMATOLOGY CONTROL/MULTIPLE R&D Systems, Inc. | JPK |
| Oct 26, 1990 | K904461 | METER TRAX Hematronix, Inc. | JPK |
| Oct 23, 1990 | K904464 | CBC-LASER(R) HEMATOLOGY CONTROL/MULTIPLE-MODIFIED R&D Systems, Inc. | JPK |
| Jan 29, 1990 | K900017 | REP GLYCO CONTROL NORMAL(3209) AND ABNORMAL(3210) Helena Laboratories | JPK |
| Jul 25, 1989 | K893895 | HEMATOLOGY CONTROL MIXTURES FOR QUALITY CONTROL Intercare Diagnostics, Inc. | JPK |
| May 16, 1989 | K884266 | PH BLOOD GAS CONTROL PRODUCTS Alko Diagnostic Corp. | JPK |
| Mar 23, 1989 | K890767 | NE-CHECK Streck Laboratories, Inc. | JPK |
| Feb 27, 1989 | K890749 | CBC-TECH (TM) HEMATOLOGY CONTROL/MULTIPLE R&D Systems, Inc. | JPK |
| Mar 1, 1988 | K880270 | MSI-DIFF PLUS Medical Specialties, Inc. | JPK |
| Sep 29, 1987 | K873354 | QBC VENOUS BLOOD CONTROL/MULTIPLE R&D Systems, Inc. | JPK |
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