The following data is part of a premarket notification filed by Dako Corp. with the FDA for Dako Rabbit Anti-cow S-100 Polyclonal Antibody.
| Device ID | K931192 |
| 510k Number | K931192 |
| Device Name: | DAKO RABBIT ANTI-COW S-100 POLYCLONAL ANTIBODY |
| Classification | Lambda, Antigen, Antiserum, Control |
| Applicant | DAKO CORP. 6392 VIA REAL Carpinteria, CA 93013 |
| Contact | Kim M Kosai |
| Correspondent | Kim M 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 | 1993-03-09 |
| Decision Date | 1995-04-20 |