The following data is part of a premarket notification filed by Coulter Corp. with the FDA for Cyto-stat Cd3-fitc/cd56-rdi Monoclonal Antibody Reagent With Cyto-stat/coulter Clone Msiggi-rd1/msiggi-fitc Isotypic Col.
| Device ID | K982172 |
| 510k Number | K982172 |
| Device Name: | CYTO-STAT CD3-FITC/CD56-RDI MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT/COULTER CLONE MSIGGI-RD1/MSIGGI-FITC ISOTYPIC COL |
| Classification | Counter, Differential Cell |
| Applicant | COULTER CORP. 11800 S.W. 147TH AVE. Miami, FL 33196 -2500 |
| Contact | Marion S Gide |
| Correspondent | Marion S Gide 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 | 1998-06-19 |
| Decision Date | 1998-09-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590540883 | K982172 | 000 |
| 15099590540302 | K982172 | 000 |
| 15099590537319 | K982172 | 000 |