The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for Thyroid Stiumlating Hormone (tsh-beads Assay) Test.
Device ID | K961629 |
510k Number | K961629 |
Device Name: | THYROID STIUMLATING HORMONE (TSH-BEADS ASSAY) TEST |
Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
Applicant | TECO DIAGNOSTICS 911 VIA RODEO Placentia, CA 92670 |
Contact | K C Chen |
Correspondent | K C Chen TECO DIAGNOSTICS 911 VIA RODEO Placentia, CA 92670 |
Product Code | JLW |
CFR Regulation Number | 862.1690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-04-26 |
Decision Date | 1996-09-11 |