Panels › Microbiology › Product code LQF · Class 1
Dna-Reagents, Mycobacterium Spp.
Regulation 866.3370
0510(k)s in 12 months (15 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in LQF
| Company | 510(k)s | Recalls |
|---|---|---|
| Gen-Probe, Inc. | 13 | 2 |
| Syngene, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 23, 1992 | K921435 | ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE Gen-Probe, Inc. | LQF |
| Nov 13, 1990 | K904463 | ACCUPROBE MYCOBACTERIUM KANSASII CULT CONFIRM TEST Gen-Probe, Inc. | LQF |
| Aug 23, 1990 | K897077 | ACCUPROBE MYCOBACTERIUM INTRACELLULARE CULTURE Gen-Probe, Inc. | LQF |
| Aug 23, 1990 | K896494 | ACCUPROBE MYCOBACTERIUM AVIUM CULTURE TEST Gen-Probe, Inc. | LQF |
| May 2, 1990 | K897078 | ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE Gen-Probe, Inc. | LQF |
| Apr 16, 1990 | K896492 | ACCUPROBE MYCOBACTERIUM GORDONAE CULTURE TEST Gen-Probe, Inc. | LQF |
| Apr 11, 1990 | K896493 | ACCUPROBE MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST Gen-Probe, Inc. | LQF |
| Apr 3, 1990 | K900292 | SNAP M. TUBERCULOSIS COMPLEX Syngene, Inc. | LQF |
| Apr 3, 1990 | K900202 | SNAP MYCOBACTERIA AVIUM COMPLEX Syngene, Inc. | LQF |
| Mar 13, 1989 | K890089 | RAPID DIAG. SYSTEM FOR MYCOBACTERIUM GORDONAE Gen-Probe, Inc. | LQF |
| Jul 30, 1987 | K871795 | RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIUM TUBER. Gen-Probe, Inc. | LQF |
| Apr 20, 1987 | K864597 | GEN-PROBE RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIA Gen-Probe, Inc. | LQF |
| Nov 10, 1986 | K862614 | RAPID IDENTI. TEST FOR MYCOBACTERIUM TB COMPLEX Gen-Probe, Inc. | LQF |
| Nov 10, 1986 | K862613 | RAPID IDENT. TEST FOR MYCOBACTERIUM AVIUM COMPLEX Gen-Probe, Inc. | LQF |
| Jul 2, 1986 | K860782 | GEN-PROBE MYCOBACTERIUM RAPID CONFIRMATION SYSTEM Gen-Probe, Inc. | LQF |
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