The following data is part of a premarket notification filed by American Dade with the FDA for Stratus Immunoassay Controls, Levels I, Ii, Iii.
| Device ID | K860906 |
| 510k Number | K860906 |
| Device Name: | STRATUS IMMUNOASSAY CONTROLS, LEVELS I, II, III |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
| Contact | Karen H Darcy |
| Correspondent | Karen H Darcy AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-10 |
| Decision Date | 1986-05-29 |