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 |