The following data is part of a premarket notification filed by Syngene, Inc. with the FDA for Snap M. Tuberculosis Complex.
Device ID | K900292 |
510k Number | K900292 |
Device Name: | SNAP M. TUBERCULOSIS 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 | 1990-01-22 |
Decision Date | 1990-04-03 |