The following data is part of a premarket notification filed by Armkel, Llc. with the FDA for Bactigen S. Pneumoniae.
| Device ID | K831887 |
| 510k Number | K831887 |
| Device Name: | BACTIGEN S. PNEUMONIAE |
| Classification | Antisera, All Types, Streptococcus Pneumoniae |
| Applicant | ARMKEL, LLC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GWC |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-13 |
| Decision Date | 1983-09-26 |