The following data is part of a premarket notification filed by Coulter Corp. with the FDA for Cyto-stat/coulter Clone Cd3 (igg1)-fitc/b4-rd1 Mon.
| Device ID | K926124 |
| 510k Number | K926124 |
| Device Name: | CYTO-STAT/COULTER CLONE CD3 (IGG1)-FITC/B4-RD1 MON |
| Classification | Counter, Differential Cell |
| Applicant | COULTER CORP. (31-B08) P.O. BOX 169015 Maimi, FL 33116 -9015 |
| Contact | Gregory M Butchko |
| Correspondent | Gregory M Butchko COULTER CORP. (31-B08) 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 | 1992-12-04 |
| Decision Date | 1993-07-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590538170 | K926124 | 000 |