The following data is part of a premarket notification filed by Dako Corp. with the FDA for Dako Mouse Anti-human T-cell, Cd3/rpe-cy5, Clone Ucht1 & Dako Mouse Anti-human T-cell, Cd3/rpe, Clone Ucht1.
| Device ID | K991402 |
| 510k Number | K991402 |
| Device Name: | DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE, CLONE UCHT1 |
| 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 | 1999-04-22 |
| Decision Date | 1999-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05700572028352 | K991402 | 000 |
| 05700572028161 | K991402 | 000 |