The following data is part of a premarket notification filed by Kronus with the FDA for Modified Kronus Test Kit For Antibodies To (tpo).
| Device ID | K894364 |
| 510k Number | K894364 |
| Device Name: | MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO) |
| Classification | System, Test, Thyroid Autoantibody |
| Applicant | KRONUS P.O. BOX 1075 SUITE 312 Dana Point, CA 92629 |
| Contact | Doerschuk, Phd |
| Correspondent | Doerschuk, Phd KRONUS P.O. BOX 1075 SUITE 312 Dana Point, CA 92629 |
| Product Code | JZO |
| CFR Regulation Number | 866.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-14 |
| Decision Date | 1989-07-25 |