The following data is part of a premarket notification filed by Biomerica, Inc. with the FDA for Thyroglobulin Autoantibody Enzyme Immunoassay.
Device ID | K936010 |
510k Number | K936010 |
Device Name: | THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY |
Classification | Thyroglobulin, Antigen, Antiserum, Control |
Applicant | BIOMERICA, INC. 1533 MONROVIA AVE. Newport Beach, CA 92663 |
Contact | Perry G Rucker |
Correspondent | Perry G Rucker BIOMERICA, INC. 1533 MONROVIA AVE. Newport Beach, CA 92663 |
Product Code | DDC |
CFR Regulation Number | 866.5870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-12-16 |
Decision Date | 1994-07-18 |