Coulter Immunology
Hialeah, FL, US
Coulter Immunology appears in FDA device records in Hialeah, FL. FDA records list 16 510(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
- 16
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 16 510(k) clearances for Coulter Immunology between 1988 and 1993. The busiest year on record is 1989, with 6. The most recent is 1993, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 3 |
| 1989 | 6 |
| 1990 | 3 |
| 1991 | 2 |
| 1993 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K922745 | CYTO-STAT/COULTER CLONE CD3(IGG1)-FITC/T4-RD1 | GKZ | Substantially Equivalent | |
| K922744 | CYTO-STAT/COULTER CLONE CD 3(IGG1)-FITC/T8-RD1 | GKZ | Substantially Equivalent | |
| K910473 | CYTO-STAT(R)/COULTER CLONE(R) T11-RD1/B4-FITC | GKZ | Substantially Equivalent | |
| K911793 | COULTERCLONE | GKZ | Substantially Equivalent | |
| K893853 | COULTER CLONE T8 MONOCLONAL ANTIBODY | GKZ | Substantially Equivalent | |
| K893852 | COULTER CLONE T4 MONOCLONAL ANTIBODY | GKZ | Substantially Equivalent | |
| K894179 | COULTER CLONE(R) MY4 MONOCLONAL ANTIBODY | GKZ | Substantially Equivalent | |
| K895917 | CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC MONO ANTI | GKZ | Substantially Equivalent | |
| K884605 | COULTER CLONE MO2 | GKZ | Substantially Equivalent | |
| K893419 | COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM) | DEW | Substantially Equivalent | |
| K884020 | COULTER CLONE B4 MONOCLONAL ANTIBODY | GKZ | Substantially Equivalent | |
| K883753 | COULTER CLONE T1 MONOCLONAL ANTIBODY | GKZ | Substantially Equivalent | |
| K883710 | COULTER CLONE T3 MONOCLONAL ANTIBODY | GKZ | Substantially Equivalent | |
| K884346 | CYTO-STAT/COULTER CLONE T11-RD1/B1-FITC MONO. ANTI | GKZ | Substantially Equivalent | |
| K883836 | COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II | GGK | Substantially Equivalent | |
| K882557 | COULTER CLONE B1 MONOCLONAL ANTIBODY | GKZ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
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