Company ยท US
Coulter Immunology
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 1993. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 5, 1993 | K922745 | CYTO-STAT/COULTER CLONE CD3(IGG1)-FITC/T4-RD1 Coulter Immunology | GKZ |
| Feb 5, 1993 | K922744 | CYTO-STAT/COULTER CLONE CD 3(IGG1)-FITC/T8-RD1 Coulter Immunology | GKZ |
| Oct 31, 1991 | K910473 | CYTO-STAT(R)/COULTER CLONE(R) T11-RD1/B4-FITC Coulter Immunology | GKZ |
| Jul 9, 1991 | K911793 | COULTERCLONE Coulter Immunology | GKZ |
| Mar 2, 1990 | K893853 | COULTER CLONE T8 MONOCLONAL ANTIBODY Coulter Immunology | GKZ |
| Mar 2, 1990 | K893852 | COULTER CLONE T4 MONOCLONAL ANTIBODY Coulter Immunology | GKZ |
| Feb 12, 1990 | K894179 | COULTER CLONE(R) MY4 MONOCLONAL ANTIBODY Coulter Immunology | GKZ |
| Dec 29, 1989 | K895917 | CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC MONO ANTI Coulter Immunology | GKZ |
| Aug 15, 1989 | K884605 | COULTER CLONE MO2 Coulter Immunology | GKZ |
| Aug 3, 1989 | K893419 | COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM) Coulter Immunology | DEW |
| Feb 3, 1989 | K884020 | COULTER CLONE B4 MONOCLONAL ANTIBODY Coulter Immunology | GKZ |
| Feb 3, 1989 | K883753 | COULTER CLONE T1 MONOCLONAL ANTIBODY Coulter Immunology | GKZ |
| Feb 3, 1989 | K883710 | COULTER CLONE T3 MONOCLONAL ANTIBODY Coulter Immunology | GKZ |
| Dec 27, 1988 | K884346 | CYTO-STAT/COULTER CLONE T11-RD1/B1-FITC MONO. ANTI Coulter Immunology | GKZ |
| Nov 30, 1988 | K883836 | COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II Coulter Immunology | GGK |
| Sep 14, 1988 | K882557 | COULTER CLONE B1 MONOCLONAL ANTIBODY Coulter Immunology | GKZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||