The following data is part of a premarket notification filed by Microbix Biosystems, Inc. with the FDA for Herpes Hominus I-comple Fix Antigen & Negative Clt.
| Device ID | K852931 |
| 510k Number | K852931 |
| Device Name: | HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLT |
| Classification | Antisera, Cf, Herpesvirus Hominis 1,2 |
| Applicant | MICROBIX BIOSYSTEMS, INC. 341 BERING AVENUE TORONTO, ONTARIO M9A 4X3 Canada, CA |
| Contact | William J Gastle |
| Correspondent | William J Gastle MICROBIX BIOSYSTEMS, INC. 341 BERING AVENUE TORONTO, ONTARIO M9A 4X3 Canada, CA |
| Product Code | GQO |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-09 |
| Decision Date | 1985-11-12 |