The following data is part of a premarket notification filed by Gen-probe, Inc. with the FDA for Accuprobe Mycobacterium Avium Culture Test.
Device ID | K896494 |
510k Number | K896494 |
Device Name: | ACCUPROBE MYCOBACTERIUM AVIUM CULTURE TEST |
Classification | Dna-reagents, Mycobacterium Spp. |
Applicant | GEN-PROBE, INC. 9880 CAMPUS POINT DR. San Diego, CA 92121 |
Contact | Bruni, Phd |
Correspondent | Bruni, Phd 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 | 1989-11-13 |
Decision Date | 1990-08-23 |