The following data is part of a premarket notification filed by Dako Corp. with the FDA for Dako Ita, Immunoglobulin M (igm).
| Device ID | K862184 |
| 510k Number | K862184 |
| Device Name: | DAKO ITA, IMMUNOGLOBULIN M (IGM) |
| Classification | Gamma Globulin, Antigen, Antiserum, Control |
| Applicant | DAKO CORP. 22 NORTH MILPAS ST. Santa Barbara, CA 93103 |
| Contact | Brooks, Ph.d. |
| Correspondent | Brooks, Ph.d. DAKO CORP. 22 NORTH MILPAS ST. Santa Barbara, CA 93103 |
| Product Code | DAH |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-09 |
| Decision Date | 1986-08-19 |