The following data is part of a premarket notification filed by Dako Corp. with the FDA for Monoclonal Mouse Anti-human Cd30, Ki-1 Antigen, Ber-h2 Antibody For Immunoenzymatic Staining (product Code No. Mo751).
| Device ID | K965022 |
| 510k Number | K965022 |
| Device Name: | MONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIBODY FOR IMMUNOENZYMATIC STAINING (PRODUCT CODE NO. MO751) |
| Classification | Lambda, Antigen, Antiserum, Control |
| Applicant | DAKO CORP. 6392 VIA REAL Carpinteria, CA 93013 |
| Contact | Bret A Cook |
| Correspondent | Bret A Cook 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 | 1996-12-16 |
| Decision Date | 1997-11-06 |
| Summary: | summary |