The following data is part of a premarket notification filed by Dako Corp. with the FDA for Mouse Anti-human Cd4, T-cell, Helper/inducer/fitc & Cd8, T-cell, Suppressor/cytotoxic/rpe.
| Device ID | K960887 |
| 510k Number | K960887 |
| Device Name: | MOUSE ANTI-HUMAN CD4, T-CELL, HELPER/INDUCER/FITC & CD8, T-CELL, SUPPRESSOR/CYTOTOXIC/RPE |
| 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 | 1996-03-04 |
| Decision Date | 1996-05-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05700572028406 | K960887 | 000 |