Coulter Corp.
Hialeah, FL, US
Coulter Corp. appears in FDA device records in Hialeah, FL. FDA records list 51 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 51
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 51FDA records hold 51 510(k) clearances for Coulter Corp. between 1989 and 2000. The busiest year on record is 1990, with 16. The most recent is 2000, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 2 |
| 1990 | 16 |
| 1991 | 1 |
| 1992 | 1 |
| 1993 | 4 |
| 1994 | 2 |
| 1995 | 4 |
| 1996 | 6 |
| 1997 | 6 |
| 1998 | 3 |
| 1999 | 5 |
| 2000 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K993356 | COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES | GKZ | Substantially Equivalent | |
| K991070 | COULTER Z2 ANALYZER | GKL | Substantially Equivalent | |
| K990327 | RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS | GKZ | Substantially Equivalent | |
| K990172 | TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLA | GKZ | Substantially Equivalent | |
| K990352 | COULTER AC T DIFF 2 ANALYZER | GKZ | Substantially Equivalent | |
| K984216 | IMMUNO-TROL CONTROL CELLS | JPK | Substantially Equivalent | |
| K982167 | CYTO-STAT TRICHROME CD45-FITC/CD19-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1 | GKZ | Substantially Equivalent | |
| K982166 | CYTO-STAT TRICHROME CD45-FITC/CD56-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1 | GKZ | Substantially Equivalent | |
| K982172 | CYTO-STAT CD3-FITC/CD56-RDI MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT/COULTER CLONE MSIGGI-RD1/MSIGGI-FITC ISOTYPIC COL | GKZ | Substantially Equivalent | |
| K973634 | COULTER AC.T DIFF ANALYZER | GKZ | Substantially Equivalent | |
| K971469 | COULTER ACT TRON CELL CONTROL | JPK | Substantially Equivalent | |
| K964988 | COULTER AC.T SERIES ANALYZER | GKZ | Substantially Equivalent | |
| K963263 | TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS AND CYTO-STAT TERTRACHROME CD45-FITC/CD4-RDI/CD8-ECD/CD3-PC5 | GKZ | Substantially Equivalent | |
| K962768 | CYTO-STAT TRICHROME CD45-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANITBODY REAGENT W/ISOTYPIC CONTROL | GKZ | Substantially Equivalent | |
| K962305 | CYTO-STAT TRICHROME CD45-FITC/CD8-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT IWTH ISOTYPIC CONTROL | GKZ | Substantially Equivalent | |
| K964618 | CYTO-STAT TRICHROME CD8-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME MSIGGI-FITC/MSIGGI-RD1 | GKZ | Substantially Equivalent | |
| K962988 | COULTER GEN-S SYSTEM | GKL | Substantially Equivalent | |
| K961278 | COULTER STKS ANALYZER WITH CD4 & CD8 LYMPHOCYTE ANALYSIS | GKZ | Substantially Equivalent | |
| K954688 | FLOW-COUNT COULTER FLUOROSPHERES | GKZ | Substantially Equivalent | |
| K955334 | COULTER LINEARITY CONTROL | JPK | Substantially Equivalent | |
| K955016 | 4C PLUS COULTER CELL CONTROL | JPK | Substantially Equivalent | |
| K952308 | COULTER Z 1 | GKL | Substantially Equivalent | |
| K950742 | CYTO-STAT/COULTER CLONE CD3-ECD/T4-RD1/T8-FITC MONOCLONAL ANTIBOEY REAGENT | GKZ | Substantially Equivalent | |
| K950949 | COULTER MH025A | GKZ | Substantially Equivalent | |
| K943967 | ONYX | GKZ | Substantially Equivalent | |
| K944751 | COULTER FLOW SET | JPK | Substantially Equivalent | |
| K935953 | COULTER MULTI Q PREP | GKH | Substantially Equivalent | |
| K932030 | COULTER STKS WITH RETICULOCYTE ANALYSIS CAPABILITY | GKZ | Substantially Equivalent | |
| K930913 | COULTER MH015 (DIFFERENTIAL CELL COUNTER) | GKZ | Substantially Equivalent | |
| K926124 | CYTO-STAT/COULTER CLONE CD3 (IGG1)-FITC/B4-RD1 MON | GKZ | Substantially Equivalent | |
| K925344 | COULTER NEW METH BLUE PREPREP RETIC/MAXM W/AUTOLOA | GKZ | Substantially Equivalent | |
| K923421 | COULTER BETA-2 MICROGLOBULIN IMMUNOASSAY | JZG | Substantially Equivalent | |
| K914486 | COULTER CARBON DIOXIDE REAGENT | KHS | Substantially Equivalent | |
| K902174 | COULTER HDL - CHOLESTEROL REAGENT | LBR | Substantially Equivalent | |
| K902172 | COULTER CREATININE REAGENT | CGX | Substantially Equivalent | |
| K902229 | COULTER CARBON DIOXIDE REAGENT | KHS | Substantially Equivalent | |
| K902199 | COULTER DIRECT BILIRUBIN | CIG | Substantially Equivalent | |
| K902175 | COULTER UREA NITROGEN REAGENT | CDQ | Substantially Equivalent | |
| K902173 | COULTER SERUM IRON/UIBC REAGENT | JIY | Substantially Equivalent | |
| K901268 | COULTER ALBUMIN REAGENT | CIX | Substantially Equivalent | |
| K901267 | COULTER CK (CREATINE KINASE) REAGENT | CGS | Substantially Equivalent | |
| K901266 | COULTER TOTAL BILIRUBIN REAGENT | CIG | Substantially Equivalent | |
| K901264 | COULTER GAMMA-GT (GGT) REAGENT | JQB | Substantially Equivalent | |
| K900231 | COULTER CALCIUM REAGENT | CJY | Substantially Equivalent | |
| K900230 | COULTER AMYLASE REAGENT | JFJ | Substantially Equivalent | |
| K896873 | COULTER JT3 | GKZ | Substantially Equivalent | |
| K901265 | COULTER MAGNESIUM REAGENT | JGJ | Substantially Equivalent | |
| K900216 | COULTER ALP (ALK PHOS) REAGENT | CJE | Substantially Equivalent | |
| K900215 | COULTER PHOSPHORUS REAGENT | CEO | Substantially Equivalent | |
| K894651 | COULTER POSITIVE CONTROL CELLS | GGL | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CGXAlkaline Picrate, Colorimetry, Creatinine
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- GKHApparatus, Automated Blood Cell Diluting
- CJYAzo Dye, Calcium
- CIXBromcresol Green Dye-Binding, Albumin
- JFJCatalytic Methods, Amylase
- GGLControl, White-Cell
- GKLCounter, Cell, Automated (Particle Counter)
- GKZCounter, Differential Cell
- CIGDiazo Colorimetry, Bilirubin
- KHSEnzymatic, Carbon-Dioxide
- JQBKinetic Method, Gamma-Glutamyl Transpeptidase
- LBRLdl & Vldl Precipitation, Hdl
- JPKMixture, Hematology Quality Control
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- JIYPhotometric Method, Iron (Non-Heme)
- JGJPhotometric Method, Magnesium
- JZGSystem, Test, Beta-2-Microglobulin Immunological
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain