The following data is part of a premarket notification filed by Institute Virion Ltd. with the FDA for Cytomegalovirus.
Device ID | K843657 |
510k Number | K843657 |
Device Name: | CYTOMEGALOVIRUS |
Classification | Antigen, Cf (including Cf Control), Cytomegalovirus |
Applicant | INSTITUTE VIRION LTD. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | GQH |
CFR Regulation Number | 866.3175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-09-17 |
Decision Date | 1985-09-26 |