The following data is part of a premarket notification filed by Clark Laboratories, Inc. with the FDA for Encore Thyroglobulin Ige, Iga And Igm Eia.
| Device ID | K925826 |
| 510k Number | K925826 |
| Device Name: | ENCORE THYROGLOBULIN IGE, IGA AND IGM EIA |
| Classification | System, Test, Thyroid Autoantibody |
| Applicant | CLARK LABORATORIES, INC. 53 CEDAR LAKE RD. Blairstown, NJ 07825 |
| Contact | Gary Lehnus |
| Correspondent | Gary Lehnus CLARK LABORATORIES, INC. 53 CEDAR LAKE RD. Blairstown, NJ 07825 |
| Product Code | JZO |
| CFR Regulation Number | 866.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-16 |
| Decision Date | 1993-01-26 |