The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Modification To Zeus Scientific, Inc., Tpo Igg Elisa Test System.
| Device ID | K000362 |
| 510k Number | K000362 |
| Device Name: | MODIFICATION TO ZEUS SCIENTIFIC, INC., TPO IGG ELISA TEST SYSTEM |
| Classification | System, Test, Thyroid Autoantibody |
| Applicant | ZEUS SCIENTIFIC, INC. P.O. BOX 38 Raritan, NJ 08869 |
| Contact | Mark J Kopnitsky |
| Correspondent | Mark J Kopnitsky ZEUS SCIENTIFIC, INC. P.O. BOX 38 Raritan, NJ 08869 |
| Product Code | JZO |
| CFR Regulation Number | 866.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-04 |
| Decision Date | 2000-02-18 |