Company ยท US
Coulter Electronics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1994. Name variants (Inc, Corp, punctuation) are merged.
101510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GKL | Counter, Cell, Automated (Particle Counter) | 17 |
| GKZ | Counter, Differential Cell | 14 |
| JPK | Mixture, Hematology Quality Control | 8 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 4 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 4 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 3 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 3 |
| KRY | Calibrator For Platelet Counting | 3 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 2 |
| CIJ | Saccharogenic, Amylase | 2 |
| JHT | Chromatographic Separation, Cpk Isoenzymes | 2 |
| CDN | Urease, Photometric, Urea Nitrogen | 1 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 |
| CEM | Electrode, Ion Specific, Potassium | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 |
| CFM | Bathophenanthroline, Colorimetry, Iron (Non-Heme) | 1 |
| CFR | Hexokinase, Glucose | 1 |
| CHJ | Mercuric Thiocyanate, Colorimetry, Chloride | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 25, 1994 | K923951 | CD8 CYTOSPHERES KIT Coulter Electronics, Inc. | MAM |
| Apr 5, 1993 | K930119 | COULTER RETIC-C CELL CONTROL Coulter Electronics, Inc. | JPK |
| Dec 29, 1992 | K921279 | CD4 CYTOSPHERES KIT Coulter Electronics, Inc. | GKZ |
| Oct 14, 1992 | K923530 | COULTER MULTI-Q-PREP Coulter Electronics, Inc. | GKH |
| Aug 17, 1992 | K922181 | COULTER MH009 Coulter Electronics, Inc. | GKZ |
| Jul 27, 1992 | K922704 | COULTER MAXM W/ AUTOLOADER Coulter Electronics, Inc. | GKZ |
| Jul 6, 1992 | K921567 | COULTER MH017 Coulter Electronics, Inc. | GKZ |
| Jul 17, 1991 | K912133 | PX COULTER(R) CELL CONTROL Coulter Electronics, Inc. | JPK |
| Jun 17, 1991 | K911385 | COULTER(R) MH010 Coulter Electronics, Inc. | GKZ |
| Feb 26, 1991 | K905771 | COULTER DART AST (GOT) REAGENT Coulter Electronics, Inc. | CIT |
| Jan 25, 1991 | K905767 | COULTER DART ALT (GPT) REAGENT Coulter Electronics, Inc. | CKA |
| Dec 26, 1990 | K905622 | COULTER DIRECT BILLRUBIN REAGENT Coulter Electronics, Inc. | CIG |
| Dec 13, 1990 | K904866 | COULTER CK-MB ISOENZYME REAGENT Coulter Electronics, Inc. | JHT |
| Mar 29, 1990 | K897162 | COULTER CHOLESTEROL REAGENT Coulter Electronics, Inc. | CHH |
| Mar 9, 1990 | K897164 | COULTER LD (LDH-L) REAGENT Coulter Electronics, Inc. | CFJ |
| Mar 9, 1990 | K897163 | COULTER ALT (GPT) REAGENT Coulter Electronics, Inc. | CKA |
| Mar 9, 1990 | K897160 | COULTER GLUCOSE REAGENT Coulter Electronics, Inc. | CFR |
| Mar 9, 1990 | K897159 | COULTER TRIGLYCERIDES GPO REAGENT Coulter Electronics, Inc. | CDT |
| Mar 1, 1990 | K897161 | COULTER URIC ACID REAGENT Coulter Electronics, Inc. | KNK |
| Feb 23, 1990 | K897166 | COULTER TOTAL PROTEIN REAGENT Coulter Electronics, Inc. | CEK |
| Feb 23, 1990 | K897165 | COULTER AST (GOT) REAGENT Coulter Electronics, Inc. | CIT |
| Oct 30, 1989 | K894836 | DART UREA NITROGEN Coulter Electronics, Inc. | CDQ |
| Feb 22, 1989 | K885332 | COULTER FLOW RETICULOCYTE REAGENT Coulter Electronics, Inc. | GKL |
| Feb 16, 1989 | K885028 | COULTER 5P CONTROL Coulter Electronics, Inc. | GKZ |
| Dec 28, 1988 | K885093 | COULTER STKS Coulter Electronics, Inc. | GKZ |
| Sep 19, 1988 | K883503 | COULTER VISCOMETER II Coulter Electronics, Inc. | JJL |
| Aug 30, 1988 | K883055 | DART CARBON DIOXIDE Coulter Electronics, Inc. | KHS |
| May 27, 1988 | K880294 | DART PHENYTOIN Coulter Electronics, Inc. | LFO |
| Apr 4, 1988 | K880507 | COULTER VCS LEUKOCYTE DIFFERENTIAL COUNTER Coulter Electronics, Inc. | GKZ |
| Mar 9, 1988 | K875047 | COULTER CLONE T11 MONOCLONAL ANTIBODY Coulter Electronics, Inc. | GKZ |
| Feb 19, 1988 | K874838 | COULTER COUNTER MODEL T SERIES W/2-PART DIFFERENT. Coulter Electronics, Inc. | GKZ |
| Jan 19, 1988 | K874188 | COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMMUNO WRK STA Coulter Electronics, Inc. | GKM |
| Nov 4, 1987 | K874185 | DART (R) ELECTROLYTE REAGENT SYSTEM Coulter Electronics, Inc. | JGS |
| Sep 16, 1987 | K872041 | COULTER DART CK-MB ISOENZYME REAGENT SYSTEM Coulter Electronics, Inc. | JHT |
| Jul 2, 1987 | K871837 | COULTER COUNTER MODEL S-PLUS STKR Coulter Electronics, Inc. | GKZ |
| May 20, 1987 | K862122 | S-CAL HEMATOLOGY CALIBRATOR Coulter Electronics, Inc. | KRY |
| Apr 14, 1987 | K870736 | DART THEOPHYLLINE REAGENT SYSTEM Coulter Electronics, Inc. | KLS |
| Feb 12, 1987 | K864802 | DART DIGOXIN ASSAY Coulter Electronics, Inc. | LCS |
| Feb 4, 1987 | K864611 | IMMUNO-SURE Coulter Electronics, Inc. | |
| Jan 13, 1987 | K864612 | DART PHENOBARBITAL ASSAY SYSTEM Coulter Electronics, Inc. | LFN |
| Sep 4, 1986 | K863085 | COULTER COUNTER MODEL T-540 Coulter Electronics, Inc. | GKL |
| Sep 4, 1986 | K863084 | COULTER COUNTER MODEL T-890 Coulter Electronics, Inc. | GKL |
| Aug 6, 1986 | K861780 | COULTER COUNTER MODEL S PLUS JUNIOR Coulter Electronics, Inc. | GKL |
| Aug 1, 1986 | K862370 | DART AMYLASE-D.S. REAGENT SYSTEM Coulter Electronics, Inc. | CIJ |
| Dec 30, 1985 | K854708 | DART CK-MB REAGENT SYSTEM Coulter Electronics, Inc. | JHS |
| Nov 12, 1985 | K854305 | DART IRON & IRON BINDING CAPACITY REAGENT Coulter Electronics, Inc. | CFM |
| Nov 5, 1985 | K854114 | COULTER COUNTER MODEL T-660 Coulter Electronics, 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 |
Newest 50 of 101.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||