The following data is part of a premarket notification filed by Thryotec with the FDA for Thyro Test.
| Device ID | K030912 |
| 510k Number | K030912 |
| Device Name: | THYRO TEST |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | THRYOTEC 163 CABOT STREET Beverly, MA 01915 |
| Contact | Fran White |
| Correspondent | Fran White THRYOTEC 163 CABOT STREET Beverly, MA 01915 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-24 |
| Decision Date | 2003-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00722066001646 | K030912 | 000 |
| 00722066001950 | K030912 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() THYRO TEST 85671688 4300851 Dead/Cancelled |
Screening Devices Canada Inc. 2012-07-09 |