Panels › Microbiology › Product code LQO · Class 1
Dna-Reagents, Campylobacter Spp.
Regulation 866.3110
0510(k)s in 12 months (4 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in LQO
| Company | 510(k)s | Recalls |
|---|---|---|
| Gen-Probe, Inc. | 1 | 0 |
| Integrated Genetics | 1 | 0 |
| Molecular Biosystems, Inc. | 1 | 0 |
| Wampole Laboratories | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 14, 1989 | K894712 | ACCUPROBE CAMPYLOBACTER CULTURE CONFIRMATION Gen-Probe, Inc. | LQO |
| Jun 8, 1988 | K873670 | SNAP CAMPYLOBACTOR DIAGNOSTIC KIT Molecular Biosystems, Inc. | LQO |
| Mar 1, 1988 | K875101 | VIROGEN CMV ANTIBODY TEST Wampole Laboratories | LQO |
| Aug 31, 1987 | K863270 | GENE-TRAK CAMPYLOBACTER ASSAY Integrated Genetics | LQO |
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