Panels › Microbiology › Product code LLA · Class 2
Direct Agglutination Test, Toxoplasma Gondii
Regulation 866.3780
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 LLA
| Company | 510(k)s | Recalls |
|---|---|---|
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 2 | 0 |
| Ampcor, Inc. | 1 | 0 |
| Biokit USA, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 11, 1993 | K913467 | TOXOGEN Biokit USA, Inc., ES | LLA |
| Jun 9, 1989 | K890048 | QUIK-DOT TOXOPLASMOSIS Ampcor, Inc. | LLA |
| May 20, 1985 | K850768 | TOXOSCAN CARD TEST KIT Bd Becton Dickinson Vacutainer Systems Preanalytic | LLA |
| Sep 26, 1983 | K831930 | TOXO-SCREEN DA TEST Bd Becton Dickinson Vacutainer Systems Preanalytic | LLA |
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