The following data is part of a premarket notification filed by Immuno-diagnostic Products, Inc. with the FDA for Herpes.
Device ID | K811021 |
510k Number | K811021 |
Device Name: | HERPES |
Classification | Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 |
Applicant | IMMUNO-DIAGNOSTIC PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GQN |
CFR Regulation Number | 866.3305 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-04-15 |
Decision Date | 1981-11-05 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
HERPES 73420400 not registered Dead/Abandoned |
PRITCHARD, DAVID LIO E AND MR. 1983-04-06 |