The following data is part of a premarket notification filed by Gen-probe, Inc. with the FDA for Gen-probe Rapid Diagnostic System For Mycobacteria.
Device ID | K864597 |
510k Number | K864597 |
Device Name: | GEN-PROBE RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIA |
Classification | Dna-reagents, Mycobacterium Spp. |
Applicant | GEN-PROBE, INC. 9880 CAMPUS POINT DR. San Diego, CA 92121 |
Contact | Daniel L Kacian,phd |
Correspondent | Daniel L Kacian,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 | 1986-11-24 |
Decision Date | 1987-04-20 |