FDA product code LHJ: Staphylococcus Aureus Protein A Insoluble
LHJ is the FDA product code for staphylococcus aureus protein a insoluble. It is a Class I device, regulated under 21 CFR 866.3700 and reviewed by the Microbiology panel. FDA has cleared 3 510(k) submissions under LHJ, from 3 different applicants. The average 510(k) review took 72 days (median 22). FDA has posted 2 recalls for LHJ devices.
Classification
| Field | Value |
|---|---|
| Device name | Staphylococcus Aureus Protein A Insoluble |
| Device class | Class I |
| Regulation | 21 CFR 866.3700 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LHJ clearance
Top LHJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Unipath , Ltd. | 1 | 1994-07-28 |
| Immucell Corp. | 1 | 1984-08-03 |
| Oxoid U.S.A., Inc. | 1 | 1981-08-25 |
Most recent LHJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K940557 | Unipath , Ltd. | STAPHYTECT-OD | 1994-07-28 | 171 |
| K842709 | Immucell Corp. | IMMUSTAPH LATEX AGGLUTINATION KIT | 1984-08-03 | 22 |
| K812181 | Oxoid U.S.A., Inc. | STAPHYLOCOCCAL PROTEIN A INSOLUBLE | 1981-08-25 | 22 |
Recalls for LHJ devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-02-19.
Frequently asked questions
What is FDA product code LHJ?
LHJ is the FDA product code for staphylococcus aureus protein a insoluble. It is a Class I device, regulated under 21 CFR 866.3700 and reviewed by the Microbiology panel.
What device class is LHJ?
Class I, regulation 21 CFR 866.3700. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LHJ?
Across 3 cleared submissions the average was 72 days from receipt to decision (median 22).
Which companies have the most LHJ clearances?
Unipath , Ltd. (1); Immucell Corp. (1); Oxoid U.S.A., Inc. (1).
Have LHJ devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2016-02-19.
Next steps
- Run an FDA pathway report with predicate devices for product code LHJ
- Run a recall and safety report across every LHJ manufacturer
- Watch product code LHJ 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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