The following data is part of a premarket notification filed by American Dade with the FDA for Stratus N-ace (napa) Fluorometric Enzyme/immuno..
| Device ID | K860140 |
| 510k Number | K860140 |
| Device Name: | STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO. |
| Classification | Enzyme Immunoassay, N-acetylprocainamide |
| Applicant | AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
| Contact | Karen Darcy |
| Correspondent | Karen Darcy AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
| Product Code | LAN |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-14 |
| Decision Date | 1986-02-06 |