K893753 is an FDA 510(k) clearance for the DIRECTIGEN 1-2-3 DISSEMINATED CANDIDIASIS TEST. This device is classified as a Antigen, Id, Candida Albicans (Class II - Special Controls, product code LHK).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on October 16, 1989, 150 days after receiving the submission on May 19, 1989.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3165.
| 510(k) Number | K893753 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 19, 1989 |
| Decision Date | October 16, 1989 |
| Days to Decision | 150 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | LHK — Antigen, Id, Candida Albicans |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3165 |