The following data is part of a premarket notification filed by Dako Corp. with the FDA for Monoclonal Mouse Anti-human B-cell.
| Device ID | K943284 |
| 510k Number | K943284 |
| Device Name: | MONOCLONAL MOUSE ANTI-HUMAN B-CELL |
| Classification | Counter, Differential Cell |
| Applicant | DAKO CORP. 6392 VIA REAL Carpinteria, CA 93013 |
| Contact | Gretchen M Murray |
| Correspondent | Gretchen M Murray DAKO CORP. 6392 VIA REAL Carpinteria, CA 93013 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-07 |
| Decision Date | 1994-11-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05700572028468 | K943284 | 000 |