The following data is part of a premarket notification filed by American Micro Scan with the FDA for Immunoscan Direct Hemophilus Influenzae Type B Tes.
| Device ID | K854490 |
| 510k Number | K854490 |
| Device Name: | IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES |
| Classification | Antisera, All Types, H. Influenza |
| Applicant | AMERICAN MICRO SCAN 855 57TH. ST. SUITE G Sacramento, CA 95819 |
| Contact | Krista Underwood |
| Correspondent | Krista Underwood AMERICAN MICRO SCAN 855 57TH. ST. SUITE G Sacramento, CA 95819 |
| Product Code | GRP |
| CFR Regulation Number | 866.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-12 |
| Decision Date | 1985-12-27 |