The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Zeus Scientific Inc., Tpo Igg Elisa Test System..
| Device ID | K991610 |
| 510k Number | K991610 |
| Device Name: | ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM. |
| Classification | Thyroglobulin, Antigen, Antiserum, Control |
| Applicant | ZEUS SCIENTIFIC, INC. 200 EVANS WAY Branchburg, NJ 08876 |
| Contact | Mark J Kopnitsky |
| Correspondent | Mark J Kopnitsky ZEUS SCIENTIFIC, INC. 200 EVANS WAY Branchburg, NJ 08876 |
| Product Code | DDC |
| CFR Regulation Number | 866.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-10 |
| Decision Date | 1999-06-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840239027917 | K991610 | 000 |
| 04048474027914 | K991610 | 000 |