LJK
6 FDA 510(k) clearances · Product code
73 daysmedian time to decision
314 days90th percentile
6clearances measured
FDA profile
- Official device name
- Antisera, If, Toxoplasma Gondii
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3780
- Medical specialty
- Microbiology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1995: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL (K974261) | Boston Biomedica, Inc. | 1997-12-11 |
| ARD(TM) ANTIMICROBIAL REMOVAL DEVICE (K911771) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-07-01 |
| THE GOLDEN QUAD TEST (TOXO) (K861122) | Microbiological Research Corp. | 1987-02-02 |
| SOLID STATE CONTINUOUS FLOW CONTROL MODEL W/K101 (K861460) | Widran Urological Group, Ltd. | 1986-05-02 |
| TOXO IPA KIT IAN INDIRECT FLUORESCENT (K832069) | Bionetic Laboratory Products | 1983-09-26 |
| TOXOPLASMA GONDII ANTIBODY IGG (K822605) | Immulok, Inc. | 1982-10-27 |
Track LJK automatically
Every clearance here is in the API, with alerts when new ones post.