The following data is part of a premarket notification filed by Coulter Corp. with the FDA for Cyto-stat Trichrome Cd8-fitc/cd4-rdi/cd3-pc5 Monoclonal Antibody Reagent With Cyto-stat Trichrome Msiggi-fitc/msiggi-rd1.
| Device ID | K964618 |
| 510k Number | K964618 |
| Device Name: | CYTO-STAT TRICHROME CD8-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME MSIGGI-FITC/MSIGGI-RD1 |
| Classification | Counter, Differential Cell |
| Applicant | COULTER CORP. P.O. BOX 169015 Maimi, FL 33116 -9015 |
| Contact | Marion S Gaide |
| Correspondent | Marion S Gaide COULTER CORP. P.O. BOX 169015 Maimi, FL 33116 -9015 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-15 |
| Decision Date | 1996-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590540814 | K964618 | 000 |
| 15099590540531 | K964618 | 000 |