The following data is part of a premarket notification filed by Gen-probe, Inc. with the FDA for Rapid Diagnostic System For Mycobacterium Tuber..
Device ID | K871795 |
510k Number | K871795 |
Device Name: | RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIUM TUBER. |
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 | 1987-05-07 |
Decision Date | 1987-07-30 |