The following data is part of a premarket notification filed by Electro-nucleonics Laboratories, Inc. with the FDA for Antibody To Herpesvirus Hominis.
Device ID | K791058 |
510k Number | K791058 |
Device Name: | ANTIBODY TO HERPESVIRUS HOMINIS |
Classification | Antisera, Cf, Herpesvirus Hominis 1,2 |
Applicant | ELECTRO-NUCLEONICS LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GQO |
CFR Regulation Number | 866.3305 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-06-08 |
Decision Date | 1979-09-07 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
G5229026011 | K791058 | 000 |
G522902600 | K791058 | 000 |
G5229025011 | K791058 | 000 |
G5229025001 | K791058 | 000 |