The following data is part of a premarket notification filed by Armkel, Llc. with the FDA for Bactigen Salmonella-shigella Test.
| Device ID | K870813 |
| 510k Number | K870813 |
| Device Name: | BACTIGEN SALMONELLA-SHIGELLA TEST |
| Classification | Antisera, All Groups, Salmonella Spp. |
| Applicant | ARMKEL, LLC. HALF ACRE RD. P.O. BOX 1001 Cranbury, NJ 08512 |
| Contact | C Kolakowsky |
| Correspondent | C Kolakowsky ARMKEL, LLC. HALF ACRE RD. P.O. BOX 1001 Cranbury, NJ 08512 |
| Product Code | GRM |
| CFR Regulation Number | 866.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-03 |
| Decision Date | 1987-04-22 |