Panels › Hematology › Product code GKL · Class 2
Counter, Cell, Automated (Particle Counter)
Regulation 864.5200
0510(k)s in 12 months (130 all time)
0recalls in 12 months (10 all time)
7recalls that name a 510(k)
Top companies in GKL
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 4, 1986 | K860166 | PICOSCALE BLOOD CELL COUNTER, MODEL PS-5 Diagnostic Technology, Inc. | GKL |
| Feb 24, 1986 | K854678 | ERMA PC-602 PC-603 BLOOD CELL COUNTER Future Impex Corp. | GKL |
| Feb 24, 1986 | K854677 | ERMA PC-604 BLOOD CELL COUNTER Future Impex Corp. | GKL |
| Feb 5, 1986 | K853030 | TECHNICON H*1 SYSTEM (HDW) Technicon Instruments Corp. | GKL |
| Jan 17, 1986 | K853722 | PLT-4 PLATELET ANALYZER Texas Intl. Laboratories, Inc. | GKL |
| Nov 5, 1985 | K854114 | COULTER COUNTER MODEL T-660 Coulter Electronics, Inc. | GKL |
| Nov 5, 1985 | K853036 | PICOSCALE LABORSCALE, #PSL-1 & ANALYSER, #PSA-1 Diagnostic Technology, Inc. | GKL |
| Oct 10, 1985 | K853429 | COULTER COUNTER MODEL M5 Coulter Electronics, Inc. | GKL |
| Aug 30, 1985 | K851943 | COULTER VOLUME ADAPTER Coulter Electronics, Inc. | GKL |
| Jul 30, 1985 | K851736 | COULTER CHANNELYZER 256 Coulter Electronics, Inc. | GKL |
| May 13, 1985 | K850171 | SYSMEX E-3000, FULLY AUTOMATED HEMATOLOGY SYS Toa Medical Electronics USA, Inc. | GKL |
| May 2, 1985 | K850386 | SYSTEM 8000 CELL COUNTER Baker Instructions Corp. | GKL |
| Mar 26, 1985 | K845019 | CELL-DYN 1000 AUTOMATED HEMATOLOGY ANALYZER Abbott Diagnostics | GKL |
| Feb 25, 1985 | K841803 | A1 SYSTEME 8201/2 Med USA | GKL |
| Dec 5, 1984 | K843303 | COULTER COUNTER MODEL M4 Coulter Electronics, Inc. | GKL |
| Nov 13, 1984 | K843164 | COULTER COUNTER MODEL ZM Coulter Electronics, Inc. | GKL |
| Oct 23, 1984 | K844042 | BLOOD DILUTION VIAL American Scientific Products | GKL |
| Aug 16, 1984 | K842140 | PICOSCAL BLOOD CELL COUNTER PS-4 Diagnostic Technology, Inc. | GKL |
| Jul 27, 1984 | K842346 | COULTER AUTOMATIC SAMPLE HANDLER Coulter Electronics, Inc. | GKL |
| Jul 19, 1984 | K840649 | DANAM ELEC. SA-1000 Danam Electronics | GKL |
| Jun 11, 1984 | K841504 | QUICK-COUNT PLUS 2 Seragen Diagnostics, Inc. | GKL |
| Apr 17, 1984 | K840658 | QBC CENTRIFUGAL HEMATOLOGY ANALYZ Bd Becton Dickinson Vacutainer Systems Preanalytic | GKL |
| Mar 2, 1984 | K840170 | CELL-DYN 100 WHOLE BLOOD PLATELET Abbott Diagnostics | GKL |
| Feb 10, 1984 | K834568 | COULTER COUNTER M2 Coulter Electronics, Inc. | GKL |
| Feb 10, 1984 | K834372 | PHA-1 PROGRAMMABLE HEMATOLOGY ANALYZ Diagnostic Technology, Inc. | GKL |
| Jan 30, 1984 | K834026 | RDW PARAMETER FOR THE TECHNICON H6000 Technicon Instruments Corp. | GKL |
| Jan 30, 1984 | K833971 | QUICK-COUNT Seragen Diagnostics, Inc. | GKL |
| Oct 19, 1983 | K832890 | HEMACOMP 7 OR HEMATIL 7 Texas Intl. Laboratories, Inc. | GKL |
| Sep 26, 1983 | K832643 | CELL-DYN 900 HEMATOLOGY ANALYZER Abbott Diagnostics | GKL |
| Sep 12, 1983 | K832627 | TECHNICON H6000 SYSTEM Technicon Instruments Corp. | GKL |
| Sep 1, 1983 | K832420 | FACS ANALYZER Bd Becton Dickinson Vacutainer Systems Preanalytic | GKL |
| Jul 18, 1983 | K832038 | CELL-DYN 300 HEMATOLOGY ANALYZER Abbott Diagnostics | GKL |
| Jul 18, 1983 | K831368 | CELL-DYN 400 HEMOTOLOGY ANALYZER Abbott Diagnostics | GKL |
| May 13, 1983 | K830507 | SYSMEX CC-170 Toa Medical Electronics USA, Inc. | GKL |
| May 9, 1983 | K830508 | SYSMEX CC-180 Toa Medical Electronics USA, Inc. | GKL |
| May 9, 1983 | K830506 | SYSMEX CC-150 Toa Medical Electronics USA, Inc. | GKL |
| May 9, 1983 | K830505 | SYSMEX CC-130 Toa Medical Electronics USA, Inc. | GKL |
| Apr 27, 1983 | K830451 | QBC CENTRIFUGAL HEMATOLOGY SYS Bd Becton Dickinson Vacutainer Systems Preanalytic | GKL |
| Mar 1, 1983 | K823886 | PROFILE 750 BLOOD CELL COUNTER Mallinckrodt Critical Care | GKL |
| Dec 28, 1982 | K823344 | HEMATOLOGY ANALYZER Abbott Diagnostics | GKL |
| Oct 18, 1982 | K822758 | SYSMEX PDA-410 (PARTICLE DISTRIB. ANALY Toa Medical Electronics USA, Inc. | GKL |
| Jul 2, 1982 | K821575 | SYSMEX CC-800 Sysmex/Toa Medical Electronics, Inc. | GKL |
| May 28, 1982 | K821238 | CC-700 SEVEN PARAMETER, AUTOMATED HEMAA Dysmex | GKL |
| Aug 12, 1981 | K812031 | LPC II Labtronix Corp. | GKL |
| Aug 12, 1981 | K811978 | TECHNICON H6000 (90/HR) HEMATOLOGY SYS Technicon Instruments Corp. | GKL |
| Jul 24, 1981 | K803071 | PLA-MATE Labex, Inc. | GKL |
| Jun 9, 1981 | K803218 | CELL DYN 800 HEMATOLOGY ANALYZER Abbott Diagnostics | GKL |
| Apr 3, 1981 | K803128 | SERIES 810 PLATELET ANALYZER J.T. Baker Chemical Co. | GKL |
| Dec 11, 1980 | K802636 | PLATELET COUNTING KIT Streck Laboratories, Inc. | GKL |
| Oct 10, 1980 | K802094 | ORTHO SPECTRUM Ortho Instruments | GKL |
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