The following data is part of a premarket notification filed by Dako Corp. with the FDA for Dako Mouse Anti Human Cytokeratin, High Molecular Weight, Clone 34be12, Monoclonal Antibody For Immunoenzymatic Staining.
| Device ID | K971905 |
| 510k Number | K971905 |
| Device Name: | DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLONAL ANTIBODY FOR IMMUNOENZYMATIC STAINING |
| Classification | Lambda, Antigen, Antiserum, Control |
| 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 | DEH |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-23 |
| Decision Date | 1997-12-12 |
| Summary: | summary |