The following data is part of a premarket notification filed by Intl. Diagnostic Technology with the FDA for Rubella Antibody Fluoroimmunoassay.
Device ID | K841174 |
510k Number | K841174 |
Device Name: | RUBELLA ANTIBODY FLUOROIMMUNOASSAY |
Classification | Antigen, Ha (including Ha Control), Rubella |
Applicant | INTL. DIAGNOSTIC TECHNOLOGY 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | GOL |
CFR Regulation Number | 866.3510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-03-19 |
Decision Date | 1984-06-07 |