FDA product code LJK: Antisera, If, Toxoplasma Gondii
LJK is the FDA product code for antisera, if, toxoplasma gondii. It is a Class II device, regulated under 21 CFR 866.3780 and reviewed by the Microbiology panel. FDA has cleared 6 510(k) submissions under LJK, from 6 different applicants. The average 510(k) review took 97 days (median 67).
Classification
| Field | Value |
|---|---|
| Device name | Antisera, If, Toxoplasma Gondii |
| Device class | Class II |
| Regulation | 21 CFR 866.3780 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every LJK clearance
Top LJK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Boston Biomedica, Inc. | 1 | 1997-12-11 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 1991-07-01 |
| Microbiological Research Corp. | 1 | 1987-02-02 |
| Widran Urological Group, Ltd. | 1 | 1986-05-02 |
| Bionetic Laboratory Products | 1 | 1983-09-26 |
1 more applicants have LJK clearances. See the full list in Caduvo.
Most recent LJK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K974261 | Boston Biomedica, Inc. | ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL | 1997-12-11 | 28 |
| K911771 | Bd Becton Dickinson Vacutainer Systems Preanalytic | ARD(TM) ANTIMICROBIAL REMOVAL DEVICE | 1991-07-01 | 73 |
| K861122 | Microbiological Research Corp. | THE GOLDEN QUAD TEST (TOXO) | 1987-02-02 | 314 |
| K861460 | Widran Urological Group, Ltd. | SOLID STATE CONTINUOUS FLOW CONTROL MODEL W/K101 | 1986-05-02 | 14 |
| K832069 | Bionetic Laboratory Products | TOXO IPA KIT IAN INDIRECT FLUORESCENT | 1983-09-26 | 91 |
Recalls for LJK devices
openFDA lists no recalls for product code LJK.
Frequently asked questions
What is FDA product code LJK?
LJK is the FDA product code for antisera, if, toxoplasma gondii. It is a Class II device, regulated under 21 CFR 866.3780 and reviewed by the Microbiology panel.
What device class is LJK?
Class II, regulation 21 CFR 866.3780. Typical premarket route: 510(k).
How long does a 510(k) take for product code LJK?
Across 6 cleared submissions the average was 97 days from receipt to decision (median 67).
Which companies have the most LJK clearances?
Boston Biomedica, Inc. (1); Bd Becton Dickinson Vacutainer Systems Preanalytic (1); Microbiological Research Corp. (1); Widran Urological Group, Ltd. (1); Bionetic Laboratory Products (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LJK
- Run a recall and safety report across every LJK manufacturer
- Watch product code LJK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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