The following data is part of a premarket notification filed by Armkel, Llc. with the FDA for Virogen Rotatest Slide Test.
| Device ID | K853399 |
| 510k Number | K853399 |
| Device Name: | VIROGEN ROTATEST SLIDE TEST |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rotavirus |
| Applicant | ARMKEL, LLC. HALF ACRE RD. P.O. BOX 1001 Cranbury, NJ 08512 |
| Contact | Stephen Kolakowsky |
| Correspondent | Stephen Kolakowsky ARMKEL, LLC. HALF ACRE RD. P.O. BOX 1001 Cranbury, NJ 08512 |
| Product Code | LIQ |
| CFR Regulation Number | 866.3405 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-12 |
| Decision Date | 1985-11-12 |