The following data is part of a premarket notification filed by Dako Corp. with the FDA for Dako Mouse Anti-human Melanoma (dako Anti-hmb45).
| Device ID | K932136 |
| 510k Number | K932136 |
| Device Name: | DAKO MOUSE ANTI-HUMAN MELANOMA (DAKO ANTI-HMB45) |
| Classification | Lambda, Antigen, Antiserum, Control |
| Applicant | DAKO CORP. 6392 VIA REAL Carpinteria, CA 93013 |
| Contact | Kim Kosai |
| Correspondent | Kim Kosai 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 | 1993-05-03 |
| Decision Date | 1994-06-13 |