The following data is part of a premarket notification filed by Scientific Research with the FDA for Herpes Virus Agglutination Test.
Device ID | K842887 |
510k Number | K842887 |
Device Name: | HERPES VIRUS AGGLUTINATION TEST |
Classification | Antisera, Cf, Herpesvirus Hominis 1,2 |
Applicant | SCIENTIFIC RESEARCH 1249 AMBLER Abilene , TX 79601 - |
Contact | Swan |
Correspondent | Swan SCIENTIFIC RESEARCH 1249 AMBLER Abilene , TX 79601 - |
Product Code | GQO |
CFR Regulation Number | 866.3305 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-07-23 |
Decision Date | 1985-02-26 |