The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Lite(tm) Thyroid T Elisa.
Device ID | K930486 |
510k Number | K930486 |
Device Name: | QUANTA LITE(TM) THYROID T ELISA |
Classification | Thyroglobulin, Antigen, Antiserum, Control |
Applicant | INOVA DIAGNOSTICS, INC. 10451 ROSELLE ST. San Diego, CA 92121 |
Contact | Brys C Myers |
Correspondent | Brys C Myers INOVA DIAGNOSTICS, INC. 10451 ROSELLE ST. San Diego, CA 92121 |
Product Code | DDC |
CFR Regulation Number | 866.5870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-01-29 |
Decision Date | 1993-03-15 |