The following data is part of a premarket notification filed by Coulter Corp. with the FDA for Cyto-stat Trichrome Cd45-fitc/cd56-rd1/cd3-pc5 Monoclonal Antibody Reagent With Cyto-stat Trichrome Cd45-fitc/msigg1-rd1.
| Device ID | K982166 |
| 510k Number | K982166 |
| Device Name: | CYTO-STAT TRICHROME CD45-FITC/CD56-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1 |
| Classification | Counter, Differential Cell |
| Applicant | COULTER CORP. 11800 S.W. 147TH AVE. MAIL CODE 31-B06 Miami, FL 33196 -2500 |
| Contact | Marion S Gaide |
| Correspondent | Marion S Gaide COULTER CORP. 11800 S.W. 147TH AVE. MAIL CODE 31-B06 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 | 1998-06-19 |
| Decision Date | 1998-11-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590540456 | K982166 | 000 |