The following data is part of a premarket notification filed by Dako Corp. with the FDA for Mouse Anti-human Leucocyte Antigen & Dako Pap Kit.
| Device ID | K896918 |
| 510k Number | K896918 |
| Device Name: | MOUSE ANTI-HUMAN LEUCOCYTE ANTIGEN & DAKO PAP KIT |
| Classification | Lambda, Antigen, Antiserum, Control |
| Applicant | DAKO CORP. 6392 VIA REAL Carpinteria, CA 93013 |
| Contact | Debora Hinman |
| Correspondent | Debora Hinman DAKO CORP. 6392 VIA REAL Carpinteria, CA 93013 |
| Product Code | DEH |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-11 |
| Decision Date | 1990-08-27 |