Panels › Microbiology › Product code LHK · Class 2
Antigen, Id, Candida Albicans
Regulation 866.3165
0510(k)s in 12 months (4 all time)
1recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in LHK
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 16, 1989 | K893753 | DIRECTIGEN 1-2-3 DISSEMINATED CANDIDIASIS TEST Bd Becton Dickinson Vacutainer Systems Preanalytic | LHK |
| Dec 28, 1982 | K823016 | CANDIDA DETECTION SYSTEM Ramco Laboratories, Inc. | LHK |
| Oct 23, 1981 | K812741 | REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS Nolan Biological Laboratories, Inc. | LHK |
| Aug 25, 1981 | K812186 | CANDIDA IMMUNODIFFUSION SYSTEM American Scientific Products | LHK |
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