The following data is part of a premarket notification filed by Dako Corp. with the FDA for Dako Ita(tm) System, For Immunoturbidimetric Assay.
| Device ID | K871346 |
| 510k Number | K871346 |
| Device Name: | DAKO ITA(TM) SYSTEM, FOR IMMUNOTURBIDIMETRIC ASSAY |
| Classification | Complement C3, Antigen, Antiserum, Control |
| Applicant | DAKO CORP. 22 NORTH MILPAS ST. Santa Barbara, CA 93103 |
| Contact | Brooks, Phd |
| Correspondent | Brooks, Phd DAKO CORP. 22 NORTH MILPAS ST. Santa Barbara, CA 93103 |
| Product Code | CZW |
| CFR Regulation Number | 866.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-06 |
| Decision Date | 1987-04-21 |