The following data is part of a premarket notification filed by Armkel, Llc. with the FDA for Bactigen - N.menninigitidis Test.
| Device ID | K841907 |
| 510k Number | K841907 |
| Device Name: | BACTIGEN - N.MENNINIGITIDIS TEST |
| Classification | Antisera, All Groups, N. Meningitidis |
| Applicant | ARMKEL, LLC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GTJ |
| CFR Regulation Number | 866.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-08 |
| Decision Date | 1984-07-06 |