The following data is part of a premarket notification filed by Syngene, Inc. with the FDA for Snap Mycobacteria Avium Complex.
| Device ID | K900202 |
| 510k Number | K900202 |
| Device Name: | SNAP MYCOBACTERIA AVIUM COMPLEX |
| Classification | Dna-reagents, Mycobacterium Spp. |
| Applicant | SYNGENE, INC. 10030 BARNES CANYON RD. San Diego, CA 92121 |
| Contact | Philip M Fantasia |
| Correspondent | Philip M Fantasia SYNGENE, INC. 10030 BARNES CANYON RD. 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 | 1990-01-16 |
| Decision Date | 1990-04-03 |