The following data is part of a premarket notification filed by Armkel, Llc. with the FDA for Bactogen-h. Influenzae Type B.
| Device ID | K800493 |
| 510k Number | K800493 |
| Device Name: | BACTOGEN-H. INFLUENZAE TYPE B |
| Classification | Antisera, Fluorescent, All Types, Hemophilus Spp. |
| Applicant | ARMKEL, LLC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GRO |
| CFR Regulation Number | 866.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-03-04 |
| Decision Date | 1980-04-04 |