The following data is part of a premarket notification filed by Gen-probe, Inc. with the FDA for Accuprobe Mycobacterium Avium Complex Culture.
| Device ID | K897078 |
| 510k Number | K897078 |
| Device Name: | ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE |
| Classification | Dna-reagents, Mycobacterium Spp. |
| Applicant | GEN-PROBE, INC. 9880 CAMPUS POINT DR. San Diego, CA 92121 |
| Contact | Bruni, Ph.d. |
| Correspondent | Bruni, Ph.d. GEN-PROBE, INC. 9880 CAMPUS POINT DR. San Diego, CA 92121 |
| Product Code | LQF |
| CFR Regulation Number | 866.3370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-22 |
| Decision Date | 1990-05-02 |