The following data is part of a premarket notification filed by Coulter Corp. with the FDA for Cyto-stat Trichrome Cd45-fitc/cd4-rdi/cd3-pc5 Monoclonal Anitbody Reagent W/isotypic Control.
| Device ID | K962768 |
| 510k Number | K962768 |
| Device Name: | CYTO-STAT TRICHROME CD45-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANITBODY REAGENT W/ISOTYPIC CONTROL |
| Classification | Counter, Differential Cell |
| Applicant | COULTER CORP. 11800 S.W. 147TH AVE. Miami, FL 33196 -2500 |
| Contact | Marion S Gaide |
| Correspondent | Marion S Gaide COULTER CORP. 11800 S.W. 147TH AVE. Miami, FL 33196 -2500 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-17 |
| Decision Date | 1997-01-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590540418 | K962768 | 000 |