The following data is part of a premarket notification filed by Dako Corp. with the FDA for Mouse Anti-human Cd3, T-cell, Fitc And Cd4, T-cell, (helper/inducer) Rpe.
| Device ID | K961701 |
| 510k Number | K961701 |
| Device Name: | MOUSE ANTI-HUMAN CD3, T-CELL, FITC AND CD4, T-CELL, (HELPER/INDUCER) RPE |
| Classification | Counter, Differential Cell |
| Applicant | DAKO CORP. 6392 VIA REAL Carpinteria, CA 93013 |
| Contact | Gretchen M Murray, Ph.d., Rac |
| Correspondent | Gretchen M Murray, Ph.d., Rac 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 | 1996-05-02 |
| Decision Date | 1996-07-16 |
| Summary: | summary |