The following data is part of a premarket notification filed by Phadia Us Inc. with the FDA for Immunocap Thyrlobulin Immunocap.
| Device ID | K072661 |
| 510k Number | K072661 |
| Device Name: | IMMUNOCAP THYRLOBULIN IMMUNOCAP |
| Classification | Immunochemical, Thyroglobulin Autoantibody |
| Applicant | PHADIA US INC. 4169 COMMERCIAL AVE. Portage, MI 49002 |
| Contact | Martin R Mann |
| Correspondent | Martin R Mann PHADIA US INC. 4169 COMMERCIAL AVE. Portage, MI 49002 |
| Product Code | JNL |
| Subsequent Product Code | JJY |
| Subsequent Product Code | JZO |
| CFR Regulation Number | 866.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-21 |
| Decision Date | 2007-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07333066000305 | K072661 | 000 |
| 07333066019628 | K072661 | 000 |
| 07333066000770 | K072661 | 000 |
| 07333066000503 | K072661 | 000 |
| 07333066000749 | K072661 | 000 |
| 07333066000411 | K072661 | 000 |
| 07333066019567 | K072661 | 000 |
| 07333066019581 | K072661 | 000 |
| 07333066004006 | K072661 | 000 |
| 07333066004020 | K072661 | 000 |
| 07333066000237 | K072661 | 000 |
| 07333066019611 | K072661 | 000 |