The following data is part of a premarket notification filed by Dako A/s with the FDA for Dakocytomation Beta-2-microglobulin Kit, Code No. Oa 368.
| Device ID | K032692 |
| 510k Number | K032692 |
| Device Name: | DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368 |
| Classification | System, Test, Beta-2-microglobulin Immunological |
| Applicant | DAKO A/S 2128 W EVERGREEN AVE. Chicago, IL 60622 |
| Contact | Gitte Brinkmann |
| Correspondent | Gitte Brinkmann DAKO A/S 2128 W EVERGREEN AVE. Chicago, IL 60622 |
| Product Code | JZG |
| CFR Regulation Number | 866.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-02 |
| Decision Date | 2004-01-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05700572030539 | K032692 | 000 |