Panels › Microbiology › Product code LRF · Class 2
Candida Spp., Direct Antigen, Id
Regulation 866.3165
0510(k)s in 12 months (3 all time)
1recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in LRF
| Company | 510(k)s | Recalls |
|---|---|---|
| GET TESTED INTERNATIONAL AB | 0 | 1 |
| Immuno-Mycologics, Inc. | 1 | 0 |
| Lexamed | 0 | 1 |
| Medi-Tech, Inc. | 1 | 0 |
| Mercia Diagnostics , Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 30, 1988 | K883118 | ON THE SPOT CANDIDASURE Medi-Tech, Inc. | LRF |
| Mar 19, 1987 | K863499 | CANDIDATE(R) SUPER Mercia Diagnostics , Ltd., GB | LRF |
| Oct 1, 1984 | K843286 | EI-CANDIDA ENZYME IMMUNOASSAY EI1001 Immuno-Mycologics, Inc. | LRF |
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