Panels › Microbiology › Product code LJK · Class 2
Antisera, If, Toxoplasma Gondii
Regulation 866.3780
0510(k)s in 12 months (6 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in LJK
| Company | 510(k)s | Recalls |
|---|---|---|
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 0 |
| Bionetic Laboratory Products | 1 | 0 |
| Boston Biomedica, Inc. | 1 | 0 |
| Immulok, Inc. | 1 | 0 |
| Microbiological Research Corp. | 1 | 0 |
| Widran Urological Group, Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 11, 1997 | K974261 | ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL Boston Biomedica, Inc. | LJK |
| Jul 1, 1991 | K911771 | ARD(TM) ANTIMICROBIAL REMOVAL DEVICE Bd Becton Dickinson Vacutainer Systems Preanalytic | LJK |
| Feb 2, 1987 | K861122 | THE GOLDEN QUAD TEST (TOXO) Microbiological Research Corp. | LJK |
| May 2, 1986 | K861460 | SOLID STATE CONTINUOUS FLOW CONTROL MODEL W/K101 Widran Urological Group, Ltd. | LJK |
| Sep 26, 1983 | K832069 | TOXO IPA KIT IAN INDIRECT FLUORESCENT Bionetic Laboratory Products | LJK |
| Oct 27, 1982 | K822605 | TOXOPLASMA GONDII ANTIBODY IGG Immulok, Inc. | LJK |
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